7 дней назад
Responsible Pharmacist - Supply Operations Quality Manager
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Responsible Pharmacist - Supply Operations Quality Manager (Pharmaceutical Quality and Regulatory Compliance): Maintaining statutory accountability for Pfizer Laboratories in South Africa while managing local product quality systems, regulated market decisions, and outsourced GMP/GDP activities with an accent on license compliance, product control, and quality oversight. Focus on making risk-based decisions, coordinating deviations and CAPAs, overseeing third-party contractors, and maintaining inspection-ready records.
Location: Sandton, South Africa; hybrid work arrangement
Company
is a global pharmaceutical company operating a regulated manufacturing pharmacy and legal entity in South Africa.
What you will do
- Serve as the appointed Responsible Pharmacist for Laboratories (Pty) Ltd and maintain independent professional accountability for licensed pharmacy activities.
- Maintain pharmacy, GMP and SAHPRA licenses, oversee regulatory submissions, represent the legal entity during inspections, and ensure timely closure of commitments and corrective actions.
- Make or approve RP decisions on product release, quarantine, returns, rejection, destruction, recalls, withdrawals and other market actions.
- Maintain the local product quality system and coordinate deviations, complaints, CAPAs, change controls, risk assessments, quarantine alerts and market actions.
- Provide risk-based quality oversight of logistics providers and other GMP/GDP contractors, including quality agreements, qualification, audits and remediation.
- Collaborate with Regulatory, Medical, Pharmacovigilance, Supply Chain, Commercial and Legal functions while escalating patient-safety, product-quality and compliance risks.
Requirements
- Bachelor of Pharmacy or an equivalent qualification recognized in South Africa.
- Current registration as a pharmacist with the South African Pharmacy Council and eligibility for appointment as Responsible Pharmacist for the legal entity.
- At least 10 years of experience in pharmaceuticals or another highly regulated industry, including responsible pharmacist, quality, regulatory, supply or compliance work.
- Demonstrated interaction with SAHPRA and/or SAPC.
- Knowledge of the Pharmacy Act, Medicines and Related Substances Act, Good Pharmacy Practice, GDP and pharmaceutical quality principles.
- Experience with license compliance, quality systems, deviations, complaints, CAPAs, change control, documentation, audits and inspections; proficiency with Microsoft Office, SAP and Copilot.
Culture & Benefits
- Hybrid work arrangement in Sandton, South Africa.
- Cross-functional collaboration across technical, commercial, legal and medical functions.
- Emphasis on integrity, professional independence, continuous learning, accountability and sound risk-based judgement.
- Work governed by relevant global, work-group and local standard operating procedures.
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