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Contract QA Pharmacist – Pharmaceutical

Job Overview

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A multinational Pharmaceutical company is looking for a Contract QA Pharmacist is to ensure that all quality matters and all aspects of the operational business comply with GxP, legal and regulatory requirements.

 

Job Description   This position is a 12-month contract.

The Sub-Sahara Africa QA Pharmacist’s role is to ensure that all quality matters and all aspects of the operational business comply with GxP, legal and regulatory requirements and the Corporate Quality Manual and Policies.
Prevent significant quality issues or regulatory non-compliance which could lead to product stock-out or withdrawal, or which would negatively impact the company as well as its reputation within the South Africa and Sub-Saharan Africa (SSA) region.
Support  Quality in the movement towards a state of perpetual compliance.

Major Activities
1. Third-party supplier management, inspections, risk assessments.
2. Support and building good relationships to foster good business partnering.
3. Perform self-inspections and supplier/third party assessments according to schedule. Propose and monitor actions to improve/maintain quality standards. Participate in GCA audits.
4. Artwork approval: Artwork approval: timely and accurate review and approval of packaging component artwork.
5. Performance measures- Accurately produce assigned KQI measures in a timely way.
6. Day-to-day coordination and communication with external functions, e.g. distributors, analytical laboratory, customers
7. Perform product return evaluations and determine disposition.
8. Perform training to ensure continuous quality maintenance and quality improvement.
9. Take responsibility for corporate citizenship within the sphere of influence and control, and to enforce the Company Code of Conduct.
10. Create and maintain GxP documentation e.g. SOP’s, BRCF’s, product master files, tracking sheets etc.
11. Perform batch record review and related activities (e.g. PIT, reference standards ordering and management, import permit application, method transfer, sample and temperature checks) for timely market & technical release of finished goods.
12. Perform Product Quality Reviews (PQR) and Batch Manufacturing Documentation Reviews according to schedule in order to monitor the quality of products and compliance against the marketing authorization.
13. Raise, investigate, manage and actively resolve quality investigations as needed e.g. deviations, complaints, CAPAs, QEs in conjunction with third parties and operational units to minimize impact on product availability and sales.

Commitment to Diversity & Inclusion:           The Company is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum requirements

 

Education (minimum/desirable): B. Pharm or Dip. Pharmacy

Experience/ Professional requirement:

1. Registered with the South African Pharmacy Council.
2. Minimum of 2-4 years in the pharmaceutical industry (quality assurance, distribution, or third -party management) or a directly related field. Experience with SSA countries will be beneficial.
3. Good knowledge and understanding of GMP, quality management systems and quality practices. Documentation and third-party management. High compliance. Planning & organizing, analytical, communication and inter- personal skills

Send your updated CV  to Vicki  at vicki@medicalcareers.co.za

Successful applicants will be contacted within 10 days.

Only candidates can apply for this job.
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