Role Summary:
Requires an experienced QA Pharmacist who will be responsible for Product Quality System and Quality Ethos and any contractor related to GMP/GDP activities, ensuring quality compliance and adherence in line with the Regulatory Authority. The Quality Supply Chain is the main point of contact for the investigation and resolution of all product quality issues.
Duties and Responsibilities:
• Co-ordinate the product quality and compliance at PCOs, ensuring Board Of Health expectations are adhered
• Ensure to support timely implementation of Product Quality SOPs issued by Quality Supply Chain within the PCO
• Ensure adequate training of PCO colleagues in the Product Quality SOPs and support the implementation of all elements for Quality Supply Chain Training systems, including annual training on GDP/GMP.
• Review, update and implement new quality system and local regulatory requirements to enhance and align local systems and processes as required
• Review, update and implement Quality Supply Chain, Product Quality SOPs
• For quality performance assessment, ensure to collect data and reports quality metrics of PCO and contractors
• Review quality performance with Management to identify trends and improvement opportunities
• Partake in the PCO / Contractors quality management reviews and follow-up on recommended actions
• Track any GxP commitment raised by Quality Supply Chain or under Quality Supply Chain
• On all commitment opened, ensure due dates are based on risk, complexity and urgency, and deadline timeframes given are realistic in order to meet the stated requirements
• Partake in the changes committee as required and ensure approvals
• Manage changes of GMP/ GDP related activities and systems in the PCO
• Partake in preparation and coordination audits
• Supports development of CAPA plans
• Internal self-inspection process management / Support / Ensure the timely implementation of the self-inspection plan as per the assigned tasks as audited and / or auditor
• Inform Quality Supply Manager on any significant deviations and complaints, that could lead into a NTM
• Responsible for Deviation Management
• Responsible for Product Complaint Handling
• Responsible for Local Product Release & Temperature excursion
• Responsible for Local Repackaging / Relabeling operations
• Assess the returned goods and provide a disposition decision
• Manages Quarantine Alert Notices
• Attend, AQRT meetings
• Partake as needed in contactors visits/ audits.
• Review, negotiate and maintain up to date Quality Agreements of GMP/GDP contractors according to the Manager/ Sr Manager instructions
• Perform PQR's timeously as per the approved schedule.
Experience and Qualifications: (negotiable on experience)
• Bachelor of Pharmacist degree & registered with the SAPC (Receipt and Certificate) - non negotiable
• Expertise in Quality Systems (Change Control, deviations, complaint management, documentation management, audits, inspections, etc.)
• Minimum of 2-5 year’s experience in a similar role within Pharmaceutical / Biotechnology or related regulated industry
