Quality Assurance Pharmacist
Reference: JHB000099-Sines-3
Our client is looking for a Quality Assurance Pharmacist with the responsibility to oversee all key elements of the Quality Management System (QMS) and monitor its effectiveness. The role ensures quality standards and current procedures meet regulations for GxP. The QA Pharmacist coordinates and liaises with other Departments to ensure a strong Quality Assurance culture throughout the Company, continuously improving Quality Standards and providing guidance as required.
This position must assist to oversee all the quality assurance arrangements and report to senior management.
Job Summary
The Quality Assurance Pharmacist must have a deep understanding of the importance of an effective Quality Management System and has a crucial responsibility to assist in the implementation of it accordingly and to ensure it continuously meets the regulations of Good Manufacturing Practices (GMP). An effectively maintained QMS will lead to streamlined business processes as well as beneficial cost savings.
Duties & Responsibilities
Principal Duties
1. QUALITY ASSURANCE:
- All of the Company's various departmental SOPs reviewed, revised updated, and correctly authorised.
- Manage all QA departmental functions including QA document control, Site Master File, Quality Manual, and Quality Policy.
- Implement the Validation Master Plan.
- Approve and manage the approved supplier's list.
- Conduct Internal and External Audits and follow up on any deviations.
- Liaise with service providers regarding QA matters.
- Manage Non-conformance documentation and investigations.
- Support Adverse Drug Reaction (ADR) processes.
- Conduct Root Cause Analysis (RCA) and implement Corrective and Preventative Actions (CAPA).
- Manage Change Controls, Process validations, Method validations, and Product Quality Reviews.
- Conduct Quality Management Review (QMR) meetings.
- Ensure pest control programs are in place.
- Approve specification sheets for release.
- Ensure Technical Quality Agreements exist with 3rd party contractors/service providers.
- Implement a Stability Master Plan.
- Experience in Medical Devices.
2. COMPLAINTS:
- Ensure that all product quality complaints are identified, investigated, and dealt with correctly.
3. RECALLS:
- Ensure that all batches of medicine distributed are batch traceable in the event of a recall.
4. RETURNED / REJECTED GOODS:
- Ensure that goods returned are handled correctly and reasons for returns are determined.
- Final decision to re-analyze, re-pack, or destroy any returned/rejected goods.
5. GMP/GWP/GHP:
- Perform inspection audits on all third-party contractors.
- Ensure compliance with GMP and manufacturing procedures.
- Ensure proper handling and storage of products.
- Ensure self-inspection/internal audits are performed.
Secondary Duties
Training
Monitor that all employees in all Departments are fully trained to implement and maintain GxP and all approved SOPs.
Knowledge Required
- B. Pharm degree.
- Registered with the South African Pharmacy Council.
- Good computer literacy.
- Knowledge of cGMP regulations.
- Bilingual: English and Afrikaans.
Experience Required
- Minimum 5 Years QA experience.
- SOP and master QA document compilation/control.
- Thorough understanding of the South African Regulatory Environment.
Skills Required
- Strong Communication Skills.
- Ethical principles and behavior.
- Ability to work in a team.
- Deadline driven.
- Customer Focus.
- Detail oriented.
- Good analytical skills.
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