Compliance Pharmacist at Haleon

About the role

• This job has area/shift responsibility for overall compliance oversight and regulatory related activities. Ensures that products are manufactured and packed to the required quality and compliance standards accordance with statutory requirements and duties and ensures Compliance within the Value Stream.
• The Pharmacist report directly into Site Production Pharmacist. Ensure that applicable Standard Operating Procedures are followed, Monitors adherence to rules, regulations and procedures and help team to achieve business goals. Support the Team in application of HAPS basis to promote a culture of continuous process and quality improvement.
• Work extended shift during the week and on weekend when operationally required.

Key responsibilities

Includes but are not limited to:

• Ensures that all production activities comply with applicable Pharmacy Act and Medicines Act requirements.
• Monitors compliance against applicable Product Master Specifications and cGMP requirements ensuring batches produced to registered methods.
• Assures the "In Place" and "In Use" status of all GMP systems and procedures relating to the prevention of contamination, cross-contamination, mix-ups, and maintenance of good documentation practices.
• Ensures compliance to relevant Haleon policy and SOP's.
• Liaises with the Production Pharmacist and/or the Responsible Pharmacist regarding all product quality-related issues.
• Signs off all key production steps including but not limited to sign-off of Line Clearance checks, Line Opening checks, Additions to the Mix.
• Ensures that 5W1H/ QRAP/ RCA is completed after machine downtime with possible product impact.
• Initiates and coordinates Quality-related troubleshooting, problem solving and root cause investigations.
• Coordinates investigations into quality-related non-conformances including, but not limited to, line clearance failures; yield discrepancies; cGMP non-compliances and non-compliances against Master Specifications.
• Initiate, Drive, and Coordinates Customer complaints, CAPA actions, Change Control actions.
• Conducts training on the execution of SOPs relating to production activities and cGMP compliance.
• Support and translates Regulatory and Haleon QMS requirements into SOPs in the Value stream for operational deployment.
• Ensures QMS is correctly interpreted, in place and in use in the Value Stream.
• Ensure that CTR is achieved, and documents are right first time.
• Complies with EHS and Engineering standards and guidelines and site EHS procedures.
• Collates and reviews manufacturing / packing documentation.  
• Investigates reconciliation discrepancies or other quality problems. 
• Carries out other relevant non-specific duties relating to the Value Stream.

Qualifications and skills

Required

• Bachelor’s in Pharm or BSc Pharm.
• Registered as a Pharmacist with the South African Pharmacy Council.
• Ideally 5 years’ experience within a pharmaceutical production environment. 

Other Skills/Qualifications

• Registered as a Pharmacist with the South African Pharmacy Council.
• Good time management.