Senior Qa Pharmacist

Bayer Ag; Gauteng; On-site; ZAR 500 000 - 750 000; Full time

Job summary

A leading company in the pharmaceuticals sector seeks a Quality Assurance professional to ensure compliance with quality standards for medicines. The role involves operational responsibility for product release, training, and collaboration with regulatory authorities. Ideal candidates will have a B.Pharm degree and significant experience in quality assurance.

Qualifications

• At least 5 years of experience in Quality Assurance prior to appointment.
• Registered Pharmacist.

Responsibilities

• Ensure compliance with quality requirements for the release of medicines.
• Conduct GMP / GDP training for Bayer personnel.
• Manage product technical complaints and quality issues.

Skills

Communication

Organizational Skills

Analytical Skills

Project Management

Education

B.Pharm Degree

Job description

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At Bayer, we're visionaries, driven to solve the world's toughest challenges and striving for a world where 'Health for all, Hunger for none' is no longer a dream but a reality.

We do this with energy, curiosity, and dedication, always learning from diverse perspectives, expanding our thinking, growing our capabilities, and redefining the impossible.

If you're eager to build a meaningful career in a community of brilliant and diverse minds to make a real difference, Bayer is the place for you.

Job Purpose

Ensure adherence to the Bayer Quality System through SOPs, Directives, etc. Ensure compliance with quality requirements for the release of medicines for sale in line with GMP and Bayer policies. Maintain the local Bayer Quality System in accordance with Global Bayer Policies, Directives, and SOPs. Collaborate with Local Regulatory Affairs to ensure continuous supply of compliant medicines. Deputize as Country Quality Head in their absence.

Key Tasks and Responsibilities

1. Ensure compliance with quality requirements for the release of medicines, medical devices, and cosmetics in line with GMP / ISO and Bayer policies.
2. Operational responsibility for the local release of Bayer products in the Southern Africa region.
3. Ensure laboratory standards and requirements are met through collaboration with Laboratory Service Providers.
4. Audit third-party contractors and support the CQH in quality oversight of third-party activities, including QAAs and GMP / GDP audits.
5. Support CQH in conducting Self-Inspections.
6. Ensure standards and processes at local warehouses, transportation, and contract manufacturing sites are met, including activities like re-packaging, relabeling, and QC laboratory operations.
7. Conduct GMP / GDP training for Bayer personnel.
8. Collaborate with the Responsible Pharmacist and QA Manager / CQH on deviation management and local change management processes.
9. Manage product technical complaints, counterfeits, and quality issues; participate in the local Product Quality and Safety Committee.
10. Establish and maintain relationships with colleagues, healthcare professionals, third-party providers, and regulatory authorities.
11. Assist CQH with Medical Need Product responsibilities.
12. Plan, coordinate, and execute audit plans as an auditor / co-auditor, including supplier qualification activities.
13. Perform operational functions to support CQH with Consumer Health quality requirements.
14. Manage analytical method transfer activities between originator and testing laboratories.

Qualifications and Competencies

• B.Pharm Degree (minimum)
• At least 5 years of experience in Quality Assurance prior to appointment
• Registered Pharmacist
• Good communication skills and fluency in English
• Strong organizational and administrative skills
• Analytical, organizational, and communication skills
• Commercial awareness, project management skills, and adaptability
• Knowledge of pharmaceutical regulatory requirements at national and regional levels

Location: Pharmaceuticals Division

Reference Code: Bayer is committed to diversity and equal opportunity.

We welcome applications from all individuals regardless of race, national origin, gender, age, disability, religion, family status, pregnancy, sexual orientation, gender identity, or any other unlawful criterion.

We are dedicated to fair treatment of all applicants.