Site Quality Leader

4 weeks ago

Port Elizabeth, Eastern Cape, South Africa Staff Solutions Recruitment Full time

**Job Overview:**

We are seeking a highly experienced and skilled Site Quality Head to join our team at Staff Solutions Recruitment. The successful candidate will be responsible for leading the Quality Unit of Production, developing a quality culture within the unit, and ensuring compliance with international standards.

Responsibilities:

  • Management of the Quality Unit of Production Unit, ensuring effective leadership and coordination of quality-related activities.
  • Development of Quality Culture in Production Unit, promoting a culture of excellence and continuous improvement.
  • Strategic Development & Improvement of Quality Compliance of Production Unit to meet international standards, ensuring adherence to regulatory requirements.
  • Assuring of Compliance with international statutory & GMP requirements, ensuring a high level of quality and safety.
  • Acting as interface to company corporate Quality Functions and Quality Units of other company sites, fostering collaboration and knowledge sharing.
  • Integrating and aligning the site within the companys global Quality Network, ensuring seamless integration and alignment.
  • To fulfil the role of site Responsible Pharmacist and to manage Pharmaceutical Services of the company, ensuring compliance with regulatory requirements.

Requirements:

  • B. Pharm/ Dip. Pharm essential, demonstrating a strong foundation in pharmaceutical science.
  • Registration with SAPC essential, highlighting commitment to professional development.
  • Minimum 5 years managerial & leadership experience in Pharmaceutical production environment, showcasing expertise in leadership and management.
  • Minimum 5 years managerial experience in Quality Management / Quality Assurance, emphasizing strong analytical and problem-solving skills.
  • Minimum of 3 years managerial experience in pharmaceutical responsibility for finished products, either in direct role or in leadership of Responsible Pharmacist or EU Qualified Person or Authorized Person or similar functions , demonstrating a deep understanding of pharmaceutical regulations.
  • Aseptic Manufacturing experience essential, highlighting expertise in sterile manufacturing processes.
  • Extensive experience with SAHPRA, showcasing familiarity with South African regulatory requirements.
  • Extensive experience in managing & leading inspections from SAHPRA, demonstrating ability to navigate complex regulatory environments.
  • Extensive experience with international competent authorities such as US-FDA, EU Authorities e.g. MHRA, TGA, ANVISA, WHO, emphasizing adaptability and flexibility in working across different regulatory landscapes.

Estimated Salary: R1,200,000 - R1,800,000 per annum, depending on experience and qualifications.

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