Job description

Requirements

  • Entry level
  • No Education
  • Salary to negotiate
  • SOUTH AFRICA - SANDTON

Description

The Supply Chain Quality Team Leader leads the South African Affiliate Quality Operations team and provides direction and oversight for all aspects of product quality, GMP and GDP for products marketed in South Africa, including oversight of local drug product contract manufacturers, contract laboratories and logistic services providers. The Supply Chain Quality Team Leader manages all aspects of internal audits/regulatory inspections related to product quality, GMP and GDP.   The position represents the quality function at the Country Manager Forum. 

ROLE RESPONSIBILITIES


- Ensure prompt notification to management of all quality and regulatory compliance issues potentially impacting marketed product, and lead the local implementation of actions identified during Area Quality Review Team (AQRT) meetings, e.g.  recalls, communication with Regulatory Agency, local corrective/preventive actions.
- Ensure the quality system is operating effectively and in-compliance with Pfizer and regulatory requirements.
- Ensure effective processes are in place to manage complaint handling requirements and notification timelines.
- Ensure effective and efficient batch release, compliant with Pfizer requirements and local regulations
- Lead preparation for and coordination of GMP/GDP/MAH related inspections of PCO by regulatory authorities or Pfizer internal auditors.
- Lead local market actions and ensure effective completion of all required actions.
- Provide leadership, direction and development to the South Africa Affiliate Quality Operations team
- Engage with Country Management, Country Medical and Regulatory teams to ensure alignment with business objectives and support for Affiliate quality and compliance activities
- Ensure effective oversight of local contractors.
- Lead and contribute to Affiliate Quality Operations regional and global initiatives.


Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

About the company

Pfizer, is an American multinational pharmaceutical corporation headquartered in New York City, New York, with its research headquarters in Groton, Connecticut. It is among the world's largest pharmaceutical companies by revenues.

Pfizer develops and produces medicines and vaccines for a wide range of medical disciplines, including immunology, oncology, cardiology, diabetology/endocrinology, and neurology. Pfizer's products include the blockbuster drug Lipitor (atorvastatin), used to lower LDL blood cholesterol; Lyrica (pregabalin for neuropathic pain/fibromyalgia); Diflucan (fluconazole), an oral antifungal medication; Zithromax (azithromycin), an antibiotic; Viagra (sildenafil, for erectile dysfunction); and Celebrex/Celebra (celecoxib), an anti-inflammatory drug.

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