QA Pharmacist at Ascendis Health

JOB OBJECTIVE

• Final Product Release
• SOP Management and Training
• Supervision of QA GMP Technicians and QA Pharmacist Assistants
• Management of Change Control, Deviation, CAPA Systems
• Control of documents 
• External and Internal Audits
• Customers complaint Investigation
• Annual Product Review
• Quality Risk management
• Validation

TASK DESCRIPTION

• Complete review of production batch records to ensure all released batches have been manufactured in accordance with approved Master Manufacturing and Packaging Instructions and GMP
• Ensure In-process and QC results of released products conform to approved specifications
• Prepare/update/Review/Approve SOPs and ensure training is completed before effective date
• Assist QA GMP Technicians and QA Pharmacist Assistant with problems in the respective areas
• Ensure that the QA GMP Technicians and QA Pharmacist Assistant comply with GMP, Safety and Company Procedures pertaining to their respective job functions
• Administer non-compliance system (Deviation)- Provide guidance during investigation to ensure correct root cause Identification and implementation of CAPAs to eliminate or minimize future occurrences
• Manage changes to ensure continual improvement is undertaken in a timely and effective manner
• Perform and co-ordinate the investigation of customer complaints
• Perform Trend analysis of various quality parameters: monthly and quarterly basis
• Check and approve Master Documentation as required
• Manage document control: Issue, track, file, archive
• Participate in internal and external audits
• Ensure that GMP standards are maintained and all improvements are implemented in a controlled manner and in line with relevant procedures
• Develop an Annual Product Quality Review schedule and drive completion of APQRs to ensure schedule adherence
• Participate in risk assessment meeting and ensure risk assessments are completed in line with current procedures
• Ensure safety practices are adhered to and propose improvements
• Ensure good inter and intra departmental relations with all staff by showing full commitment and involvement, loyalty, openness, frankness and positive enthusiasm
• Ensure that time keeping, attendance and productivity is of a high standard daily

EDUCATION AND TRAINING

• Qualified Pharmacist and registered with the South African Pharmacy Council
• Preferably 5 years’ experience in Pharmaceutical production environment of which 2 years should be in Quality Assurance