FTC Production Pharmacist at Adcock Ingram

Key Job Outputs:

Responsible for personnel adherence to current Good Manufacturing Practice (cGMP) and Good Documentation Practice (GDP) requirements, hygiene and good housekeeping.

• Compliance with SOPs
• Ensure that SOPs training (QA and cGMP) is completed in accordance with the training plan 
• Ensure that new incumbents are put through induction training.
• Initiate, update, review and approve SOPs.
• Participate in both external and internal inspections:
• Ensure that internal audits are conducted as per schedule and that findings are closed on time as per action plan. 
• Ensure no repeat of the audit findings particularly critical or major findings 

Documentation:

• Ensuring completion of Batch manufacturing/packing records prior to submission to QA.  
• Ensure that the registers for scheduled substances (narcotics) are upto-date.
• Ensure that registers for the storage rooms where products are kept are up-to-date.

Customer complaints:

• Conduct thorough investigation for every received complaint
• Compile a comprehensive report timeously. 
• Ensure that the CAPAs are implemented.
• Complete all records and reports timeously and accurately as described in the relevant SOPs protocols and associated documentation. 

Operational activities

• Ensure that line opening/clearance, in process checks (IPC) and line closing are done in accordance with SOP. 
• Ensure that products are produced, packed and stored according to the required SOP and documentation. 
• Ensure that QMS is followed and adhered to at all times in terms of;

Documentation and investigation of Deviations,

• Raising of CAPAs, Change Controls and their timeous closure and effective implementation. 
• Reporting of non-conformities with respect to both the product and the environmental as described in the relevant SOPs. 
• Verify the identity of bulk product and printed packaging material 
• Ensure that materials and product are correctly handled, stored and recorded.
• Monitor production processes by overseeing critical process parameters of various packaging stages.
• Investigate incidents that resulted in non-conforming products
• Ensure that the staff comply with the dress code

Validation, Calibration and Qualification

• Facilitate and participate in qualification, validation studies
• Ensure effective technology and skills transfer
• Health, safety and environmental standards
• Ensuring that no disabling injuries by ensuring that protective clothing is worn and no machinery poses a safety hazard.
• Report any incident which may affect personnel health or cause injury to the SHE representative or line manager.
• Carry out any duty or requirements imposed on the company by the
• OHS Act and in accordance with your specific SHE appointment
• Human recourses (Compliance to labour law)
• Ensure that staff are offered the necessary training/skills to carry out their duties effectively and per operational requirements.
• Familiarize yourself with company policies and procedures and comply with them at all the times. 
• Any other function that the manager may delegate from time to time.

Requirements

• B. Pharm Experience in Pharmaceutical/Manufacturing will be advantageous.