The Responsible Pharmacist (RP) will act as the legally appointed person for the company’s Drug Licence (e.g., importer, wholesaler, or manufacturer licence). The RP is accountable for ensuring full compliance with all applicable pharmaceutical regulatory requirements and maintaining proper control over the handling, storage, and distribution of medicinal products. The role also includes oversight of warehouse operations to ensure compliance with Good Distribution Practice (GDP).
Key Responsibilities1. Regulatory & Licence ResponsibilitiesServe as the Responsible Person under the applicable drug licence.Ensure compliance with all regulatory requirements under the relevant authority (e.g., HSA in Singapore).Oversee activities related to importation, storage, distribution, and supply of registered pharmaceutical products.Ensure products handled are properly registered and valid for distribution.Maintain and update all licence documentation and regulatory records.Liaise with regulatory authorities during inspections, audits, and routine communications.Ensure implementation and maintenance of Good Distribution Practice (GDP) standards.Review and approve Standard Operating Procedures (SOPs) related to pharmaceutical operations.Ensure proper handling of product recalls, complaints, adverse event reporting, and pharmacovigilance activities where applicable.
2. Warehouse & Distribution OversightSupervise warehouse operations to ensure compliance with GDP requirements.Ensure proper storage conditions (temperature, humidity monitoring, segregation of products).Oversee quarantine, release, and disposition of pharmaceutical products.Ensure accurate inventory control and stock reconciliation.Review and approve product release for distribution where required.Ensure cold chain management is properly maintained.Oversee destruction and disposal of expired or damaged goods in compliance with regulatory requirements.Ensure security and restricted access to pharmaceutical storage areas.
3. Quality ManagementEstablish and maintain a Quality Management System (QMS).Conduct internal audits and risk assessments.Provide training to staff on GDP and regulatory compliance.Ensure corrective and preventive actions (CAPA) are implemented where necessary.Maintain proper documentation control and record retention.
RequirementsRegistered Pharmacist with valid practicing licence in Singapore.Minimum 3 years of experience in pharmaceutical regulatory affairs, wholesale, or distribution.Strong knowledge of Good Distribution Practice (GDP) guidelines.Experience handling regulatory inspections and audits preferred.Good documentation and organizational skills.Strong sense of accountability and compliance mindset.Research, review, analyze and coordinate data for new product submissions.Liaise and negotiate with the relevant authorities to facilitate and secure expeditious regulatory approvals.Update and maintain regulatory databases.
