Job overview:
As the Maximo Engineer, this position is to manage and maintain the Maximo system at the administrator level. Responsible to ensure that the master data is accurate, up-to-date and accessible to authorized personnel for work order management as part of routine operations. Require to work with various departments to manage Maximo system activities and ensure documentation/data meets compliance requirements.
Responsibilities:Create, update and maintain asset records (equipment, instruments etc) for the asset lifecycle from new creation, maintenance to retirement.Ensure that all master data such as frequency, schedule, work details related to the preventive maintenance plans are accurately input.Responsible for the accurate and timely data entry to support new entry creation and routine operational needs.Perform his/her work in accordance and compliant with the approved procedures and workflows for audit readiness and compliance.Provide guidance to other users on Maximo processes.Participate in system upgrades or enhancements as end user tester.Develop and maintain user guides and training materials for new/updated processes with the other sites Maximo administrators.Effective inter-departmental communication and collaboration.Ensure compliance with industry standards, company policies, and regulatory requirements.Support internal and external audits by providing necessary documentation and information.Other work related to Maximo scope arranged by the Compliance and Qualification lead.
Job requirements:Minimally a Diploma or above and at least 2-3 years of relevant work experience in asset management and maintenance processes to have a strong understanding.Good knowledge of IBM Maximo user interface and basic functionalities especially with the preventive maintenance aspect.Must have pharmaceutical industry experience for this role.Good attention to details and accuracy.Ability to work independently as well as can be a good team player. Able to communicate clearly and coordinate well with multiple users.Have a strong sense of responsibility and can withstand strong work pressure with given timeline.Be proficient in operating Office software especially Excel.Has the ability to read and write in English/Chinese, and be able to communicate in English/Chinese fluently.
Job responsibility:
EHS Program Implementation and Resource: • Develop and implement annual/quarterly EHS work plans, budgets and resource allocation schemes under Company’s EHS strategic framework• Ensure effective allocation of EHS resources such as personnel, equipment and technology to meet safety production and compliance requirements• Implement and carry out EHS goals, indicators and various management requirement set by the Company
Risk Management & Prevention Mechanism Development • Lead and implement comprehensive risk identification (JSA, HAZOP, PHA, etc), assessment and gap analysis activities. Focusing on core risk such as API production processes, equipment, chemical and operational activities• Develop, maintain and implement a dual prevention mechanism for EHS risk classification control and hazard identification and remediation • Organize the formulation and supervise the implementation of effective risk control measures and hazard rectification plans to ensure preventive measures are in place and effectively avoid accidents.
Customer and Third-party Auditing Management • Fully responsible for organizing, preparing, and welcoming EHS and sustainability audits/inspections from customers, certification bodies and government regulatory agencies (if applicable).• Serve as the main contact person for EHS, ensuring professional and efficient communication during the audit/inspection process.• Lead the Management of audit findings (CAPA) developing, tracking, and closing them to ensure timely and effective corrective actions.• Enhance customer satisfaction and maintain the company’s reputation through excellent EHS performance.
ESH System Operations and Culture Development • Develop and maintain EHS management system (in compliance with ISO 14001, ISO 45001, etc.) within the company’s EHS system framework to ensure effective operation.• Provide professional technical support to resolve day-to-day EHS issues at the site.• Develop and implement EHS promotion, safety training and activities (such as Safety Month, emergency drills) to continuously enhance EHS awareness, skills, and sense of responsibility among all employees including contractors.
Compliance Management and Accident Prevention • Ensure that site operations strictly comply with local and company’s EHS regulations and industry standards (especially those related to API manufacturing regulation).• Responsible for EHS’s requirements, compliance reporting and communication with the authorities • Lead the investigation of incidents/near misses (RCA), develop and implement corrective and preventive measures to prevent accidents.
Team Building and Management
• Building and leading a highly efficient and professional EHS team • Inspire team potential by clearly define team and individual goals, effectively stimulate each member’s initiative, enthusiasm, and creativity.• Manage and cultivate EHS team members, continuously improving the team’s professional knowledge, skills and execution capabilities through coaching, training, delegation and challenging tasks.• Establish a positive, open, and collaborative team atmosphere to promote internal communication and knowledge sharing, making the entire team vibrant and combat-ready.• Responsible for the performance management, work allocation, and daily supervision of the EHS team.
Job requirements:• Master’s degree or related qualifications with more than 10 years of relevant work experience in large pharmaceutical, Chemical engineering, safety or environmental-related fields.• Preferably a Certified Safety Professional, MOM Registered Workplace Safety Health Officer and Occupational Hygienist preferred• Possess excellent communication skills to articulate and share vision, goals, plans, strategies, and values to influence the team in achieving desired objectives.• Excellent problem-solving skills with the ability to analyze complex situation, identify roof causes & implement practical solutions.• Strong leadership and able to lead by example and have a strong sense of responsibility and can withstand strong work pressure with given timeline.• Native fluency in both English and Chinese to lead meetings and author technical documentations, and collaborate with stakeholders in Singapore and China.
Job Responsibilities:
Manage the implementation of strategies, action, policies and processes in line with the company’s business strategies and needsProvide workforce planning solution and support in relation to BU/OU at local site. Plan and execute HR initiatives in terms of Headcount Budget and etcWork closely with teams to identify hiring needs. Use right strategy of recruitment to attract the best talents and make sure target be achieved in due timeSupport the performance management process, providing guidance to managers on performance evaluations, goal setting, and development planningEnsure compliance with labor laws and regulations, as well as company policies and procedures. Partner with management to identify and address employee relations issues, design and implement programs to enhance employee engagement, satisfaction, and retentionLead organizational development and transformation initiatives to ensure that organizational structures, processes, and resource allocation are fully aligned with strategic objectivesParticipate in the enhancement and optimization of compensation and benefits systems as well as incentive programs. Effectively manage labor costs while maximizing motivational impact to improve retention of core employees and overall employee satisfactionIdentify training needs with management and facilitate learning and development initiatives to enhance employee skills and career progressionOverall data and reporting ownership with high-level of data-handling, analytical capacity, and providing monthly and annually reports and dataFocus on company brand and corporate culture development. Introduce or create activities or projects that align with the corporate culture, and drive their implementation at the local levelPerform other duties and responsibilities assigned, when necessary
Job Requirements:Bachelor degree or above5-10 years HR working experience, HR experience in pharmaceutical company and or CDMO is preferredStrong understanding of HR best practices, employment laws, and regulationsExcellent interpersonal and influence skills, ability to handle confidential and sensitive informationWith the ability to handle multiple tasks simultaneously with strong problem solving skillsExtensive communications with stakeholders in China, ability to speak and write in Mandarin fluently to work with Mandarin-speaking internal and external partners
Responsibilities:
Be familiar with the procedural documents of relevant project engineers and proficiently operate various project-related systems, such as TrackWise and WMSCommunicate effectively across departments, coordinate resources to improve project production efficiency, and resolve customer issuesIdentify potential risks in the project in advance, communicate directly with upstream departments, and provide reasonable suggestionsResponsible for receiving, reviewing, and approving project documentation, completing project transfer, identifying project risk points, and implementing targeted measures to avoid risks during project executionSelect equipment according to process requirements, and develop production plans based on project initiation notices; complete equipment coordination and reservationPrepare for production-related matters, including new product introduction, safety assessment, review of R&D reports, drafting and tracking the implementation of batch records, issuing blank batch records, training production staff, submitting and tracking equipment technical modifications, monitoring material release, change control, etc.Track project production, resolve abnormal situations in a timely manner, supervise the data integrity of executed batch records, lead deviation investigations and the establishment and implementation of CAPA, etc.Complete and share project summary Perform any other ad hoc duties as required by the Department
Qualifications:Bachelor degree or above in Pharmacy, chemical engineering or chemistry relatedStrong English and Chinese (Mandarin) communication skills — reading, writing and speaking, to liaise with internal and external stakeholders in China and overseas.Skilled in computerGood coordination and communication skillsHigh capacity of learning and executionStrong problem-solving ability
Title: Engineer/Senior Engineer (Calibration)Report: Equipment and Engineering Director
Responsibilities:Perform calibration management of instruments in accordance with regulations and internal procedures to ensure the accuracy and effectiveness of the measuring instruments in use;Responsible for preparing the annual cost budget;Responsible for completing the internal calibration of the instrument on schedule, making corresponding records, and approving the internal calibration report;Responsible for summarizing and drawing up the measuring instruments ledger and keeping the ledger updated in time;Review, register and file the relevant documents to ensure the timely, accurate and complete records.Responsible for the monthly check summary;Responsible for reviewing, applying for purchase and acceptance of corresponding measuring instruments;Complete all kinds of annual safety quality indicators issued by the department;Establish and optimize the relevant operation process, train and ensure strict implementation, report problems in time and take the initiative to solve them.Complete the assigned tasks and delegated duties related to their own duties.
Requirement:Bachelor degree or aboveInstrumentation, automation and other related majors, familiar with national metrology management regulationsProfessional in English, good conversational Mandarin skillset to communication frequently with China HQ for technical communicationGood computer skills3 years’ calibration working experience or above.Good coordination and communication skills.Good problem solving skills.Holding relevant metrological calibrator certificate is preferred
Job Title: On-site QA ScientistReporting To: QA SupervisorMain Responsibilities:Conduct on-site inspections of production workshops and warehouses to ensure compliance with GMP and relevant quality standardsReview and approve the release of raw materials, ensuring they meet quality requirements before useReview and approve the release of packaging materials, ensuring compliance with specificationsManage and issue cleaning records, ensuring traceability of the cleaning processReview master cleaning records to ensure compliance and effectiveness of cleaning proceduresHandle cleaning deviations, coordinate with relevant departments for investigation and implementation of corrective actionsReview cleaning impact assessments to evaluate the potential impact of cleaning deviations on product qualityParticipate in continuous improvement of the quality management system and promote on-site quality managementMaintain effective communication with production, warehouse, and quality-related departments to ensure smooth information flowQualifications:Bachelor’s degree or above, preferably in Pharmacy, Chemistry, Quality Management, or related fields1-3 years of experience in QA or production in the pharmaceutical industry，familiar with GMP and related regulatory requirementsProficient in on-site quality management processes; capable of working communication in both Chinese and EnglishStrong communication and coordination skills with a team-oriented mindsetDetail-oriented, responsible, with strong problem-solving and analytical abilities
Job Title: Analytical QA Scientist Reporting To: QA SupervisorMain Responsibilities:Review Installation Qualification (IQ) and Operational Qualification (OQ) documents for instruments to ensure compliance with relevant standards and regulationsReview Preventive Maintenance (PM) records of instruments to ensure timely and complete maintenance activitiesReview instrument calibration records to ensure instrument performance meets requirements and data accuracyReview Out of Specification (OOS) investigation reports, track and drive effective resolution of issuesParticipate in and conduct on-site laboratory inspections to ensure laboratory operations comply with GMP and relevant quality systemsAssist in continuous improvement of the quality management system and promote quality compliance initiativesCoordinate and communicate with relevant departments to support investigation and corrective actions of quality issues
Qualifications:2 to 5 years of relevant experience in analytical chemistry, familiar with instrument analysis and quality management processesBachelor’s degree or above, preferably in Analytical Chemistry or related fieldsFamiliar with Singapore Pharmacopoeia, United States Pharmacopeia (USP), and European Pharmacopoeia (EP).Familiar with GMP, quality management systems, and relevant regulatory requirementsStrong communication and coordination skills with a sense of responsibility; able to independently complete audits and inspectionsDetail-oriented and rigorous work attitude, capable of identifying and resolving quality issuesFluent in both Chinese and English, capable of professional bilingual communication and report writing
Responsibilities:Process safety and unit operation evaluationEquipment modification implementation and following upMonitoring project unit operationInvolving in deviation investigation, participate in CAPA and document trainingResponsible for the equipment release for cleaningPerform any other ad hoc duties as required by the Department
Qualifications:Bachelor degree or above in Pharmacy or chemistry relatedStrong English and Chinese (Mandarin) communication skills — reading, writing and speaking, to liaise with internal and external stakeholders in China and overseas.Good computer skillsGood work coordination and communication skillsGood leadership skills and ability to develop subordinatesStrong problem-solving ability
Responsibilities:Perform release test as per procedure.Perform Lab tests, calculations and necessary reviewing of Lab records.Timely report lab issues of any case and ensure GMP compliance.Timely document the observations in case of Lab event, OOX and deviations and involve in the investigations if necessary.Involve the update the lab procedure, ensure execution.Use instruments as per Lab procedure, maintain Lab equipment as in good order, conduct preliminary trouble shooting, timely report instrument issues.Use instruments as per Lab procedure, maintain Lab equipment as in good order, conduct preliminary trouble shooting, timely report instrument issues.Proactively study regulatory documents from various countries, such as BP, USP, JP, and EP, and refer to these documents when updating internal proceduresParticipate in customer audits and government inspections, promptly address identified issues, and ensure GMP complianceTimely track work progress, strengthen communication with internal and external clients, and establish stable and good relationshipsPerform any other ad hoc duties as required by the Department
Qualifications:Diploma or above in Pharmacy or Chemistry related majorUnderstand pharmaceutical production, testing, and quality management; familiar with GMP regulations.Preferred to be proficient in English and Chinese, fluent in spoken English and Chinese to liaise with internal and external stakeholders in China and Overseas Good computer skills.At least one-year experience of Lab related work.Proficient in analytical testing and quality management, familiar with the structure and working principles of analytical instrumentsFamiliar with industry laws and regulations regarding technical specifications for analytical operationFamiliar with industry requirements for data integrity of analytical software; candidates with experience in computerized systems validation will be given priorityStrong ability to handle on-site issues, with good coordination, communication, and execution skills;Detail-oriented, proactive, and able to work under pressureAbility to determine problems, gather information, understand facts, and draw correct and effective conclusions through scientific reasoning.Project management and tracking skills.
Responsibilities:
Responsible for implementing and executing GMP and EHS related SOPs and TWI procedures to ensure that all operations comply with GMP and EHS requirements.Responsible for guiding and summarizing warehouse 5S management to ensure a clean warehouse environment and orderly, safe storage of goods.Responsible for guiding the timely and accurate operations of receiving, inspecting, warehousing, location transfers, issuing, and returning goods, and providing suggestions for process improvements to ensure material records are accurate.Responsible for guiding the repackaging, clearing, and timely recording of materials, inspecting the compliance of repackaging operations, and proposing process improvements.Responsible for ensuring that warehouse storage conditions meet requirements, and that goods are packaged intact and clean.Responsible for summarizing and analyzing warehouse cleanliness and inspection conditions, as well as warehouse anomalies, and providing suggestions for corrections.Responsible for the daily maintenance, repair, scrapping, and replacement statistics and analysis of warehouse facilities and equipment.Responsible for checking the timeliness and accuracy of warehouse system data, analyzing, handling, and proposing preventive measures for data anomalies.Responsible for tracking project production plans and the arrival and usage of project materials, providing feedback on unreasonable delivery plans to effectively control inventory.Responsible for guiding and supervising the application for disposal of obsolete materials and confirming the disposal of scrapped materials.Responsible for quarterly warehouse inventory, organizing inventory counts and analyzing inventory reports.Responsible for organizing and guiding the drafting, revision, change, and deviation handling of relevant documents for the position.Perform any other ad hoc duties as required by the Department
Qualifications:Bachelor and above in Chemical Engineering, Pharmacy, and Logistics-related majorsGood English reading and writing skills, prefer to be able to communicate in Mandarin to liaise with internal and external stakeholders in China and overseaswarehouse management or logistics work experience in the chemical or pharmaceutical industry preferredPossess good communication, coordination, and problem-solving skillsStrong organizational, coordination, and leadership skills
