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Compliance Pharmacist

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Haleon

1mo ago

  • Job
    Full-time
    Senior Level
  • Legal
    Healthcare
  • Cape Town
  • Quick Apply

AI generated summary

  • You need a Bachelor's in Pharmacy, registration with the South African Pharmacy Council, 5 years in pharmaceutical production, and good time management skills.
  • You will ensure compliance with regulations, monitor production quality, conduct trainings, manage investigations, and coordinate quality-related actions within cGMP frameworks.

Requirements

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

Responsibilities

  • 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.

FAQs

What is the primary responsibility of a Compliance Pharmacist at Haleon?

The Compliance Pharmacist is responsible for overall compliance oversight and regulatory-related activities to ensure that products are manufactured and packed according to required quality and compliance standards, in accordance with statutory requirements.

What qualifications are required for this position?

A Bachelor’s degree in Pharmacy (BSc Pharm) and registration as a Pharmacist with the South African Pharmacy Council are required. Ideally, candidates should have at least 5 years of experience in a pharmaceutical production environment.

What key responsibilities does the Compliance Pharmacist have?

Key responsibilities include monitoring compliance with applicable Pharmacy Act and Medicines Act requirements, ensuring adherence to product specifications, investigating non-conformances, coordinating quality-related troubleshooting, and conducting training on SOPs.

Is experience in a pharmaceutical production environment essential for this role?

Yes, ideally a minimum of 5 years’ experience within a pharmaceutical production environment is preferred.

What kind of team dynamics can I expect in this role?

The Compliance Pharmacist will work closely with the Site Production Pharmacist, liaising with various team members to ensure compliance and drive a culture of continuous improvement.

Are there specific hours of work expected for this position?

The Compliance Pharmacist may be required to work extended shifts during the week and on weekends when operationally necessary.

What kind of training will the Compliance Pharmacist conduct?

The Compliance Pharmacist will conduct training on the execution of Standard Operating Procedures (SOPs) related to production activities and current Good Manufacturing Practice (cGMP) compliance.

How does Haleon support Diversity, Equity, and Inclusion in the workplace?

Haleon embraces a diverse workforce by creating an inclusive environment that celebrates unique perspectives, promotes fair outcomes for everyone, and encourages respect and listening to different viewpoints.

What should I do if I require accommodations during the application process?

If you require reasonable accommodations or assistance during the application process, you should inform your recruiter with a description of the specific accommodations you are requesting.

Does Haleon provide equal opportunity employment?

Yes, Haleon is an Equal Opportunity Employer and all qualified applicants will receive equal consideration for employment regardless of their background or personal characteristics.

For Health. With Humanity

Retail & Consumer Goods
Industry
10,001+
Employees
2022
Founded Year

Mission & Purpose

Our purpose is to deliver better everyday health with humanity. #HelloHaleon