MedicalCareers

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QA Pharmacist Lead – Pharmaceutical

Job Overview

More Information

Job Purpose:
Provide leadership and oversight of QA/QC activities for the Company division in South Africa.
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, product approval delays or which could negatively impact business continuity as well the company’s reputation.
Support the organisation in the movement towards a state of perpetual compliance.

Major Accountabilities:

Major Activities
1. Manage department operations properly and efficiently to ensure commercial continuity at The Company South Africa. Contribute to the implementation, maintenance and upgrading of the local Quality System and Standard Operating Procedures.
2. Support the country QA integration activities for operational excellence and simple operation.
3. Ensure efficient information flow and effective communication of all relevant quality matters. Ensure compliance with the escalation processes.
4. Ensure CAPA’s are closed on time. Advise on the implementation of applicable Quality Standards.
5. Ensure all activities of team comply with company standards and local regulations.
6. Ensure that all products are released in accordance with the registered specifications and are released to the market in accordance with local regulations and ensure that an effective Change Control procedure is in place.
7. Provide scientific, regulatory and technical expertise to the team: Quality Responsible for The Company.
8. Support quality governance and quality planning: Country Quality Plan, The Company Quality Review Board, Maintain key quality performance indicators, and Quality Risk Assessments.
9. Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that support on all quality related matters is provided to the organisation.
10. Ensure that coordinated contact is maintained with the local Regulatory Authorities, the local partners (suppliers, third parties, licensees, and distributors) and The Company Country Quality.
11. Provide quality oversight and direction to third parties and ensure that they are qualified to perform their activities in compliance with the Company Quality Standards and local regulatory requirements.
12. Ensure readiness for GxP regulatory inspections.
13. Ensure management of external inspections, complaints, recalls, counterfeits and product tampering according to the Country Quality Manual and local written procedures. Support/participate in NEM cases as required.
14. Support local audits within the organization and at 3rd parties, as appropriate. Ensure that any deficiencies identified through audits or other means are addressed through the timely implementation of effective appropriate corrective and preventive actions.
15. Support Quality related training. Ensure that training is performed in a timely manner, documented and its effectiveness checked
16. Ensure that Quality personnel are competent to perform their responsibilities. Ensure robust performance management of associates and self. Provide active mentoring and coaching of associates.
17. Support local and global projects when required.
18. Provide support on the management of the budget.

B. Pharm or Dip. Pharmacy

1. Registered with the South African Pharmacy Council.
2. Three to five years in the pharmaceutical industry (quality assurance, quality control, registration or production) or a directly related field.
3. Good knowledge and understanding of GMP, quality systems and quality practices. Product release, documentation, process and third party management. Knowledge of the pharmaceutical industry. Customer and results focus important to manage various tasks and conflicting priorities. High compliance. Planning & organising, Analytical, attention to detail and accuracy, Interpersonal skills: Strong communication skills and ability to impact, influence and collaborate with key stakeholders. Operate at both strategic and operational level. Computer literate.

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

Successful applicants will be contacted within a week

Only candidates can apply for this job.
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