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Regulatory Compliance Specialist

1 week ago

Randburg, Gauteng, South Africa Mvg Recruitment Specialists Full time

About the Role:

We are seeking a highly skilled Regulatory Compliance Specialist to join our team in the Pharmaceutical Manufacturing industry.

Key Responsibilities:

  1. Audit Planning and Execution: Develop and execute annual audit plans for internal and external audits, ensuring timely closure of observations.
  2. KPI Reporting & Annual Quality Management Review: Provide required inputs for KPI reporting related to Quality Assurance and prepare slides for the Annual Quality Management Review Meeting.
  3. Supplier Evaluation and Approval: Maintain a system for supplier evaluation and approval, coordinating corrective actions from supplier performance reports.
  4. Standard Operating Procedures: Ensure all required SOPs are initiated, updated, trained, and current, reviewing and adopting relevant global SOPs locally as required.
  5. Quality Systems: Investigate, close, and follow up on Risk Assessments, CAPA, Change Controls, and Events to ensure timely closure and effectiveness of corrective action.
  6. Product Release: Review and evaluate Batch Manufacturing Records (BMRs) and Batch Release Logs (BRLs) prior to product release.
  7. General: Support Senior Quality Systems Manager / Head of Quality with related quality projects and provide effective QA support to branches and conduct QA-related investigations as needed.

Requirements:

  • Formal Qualifications: Bachelor of Pharmacy
  • 2-3 years' experience as a Vendor Supplier Auditor in a Manufacturing Pharmacy
  • Expertise of cGMP principles, ISO, quality auditing, and supplier management
  • Understanding of legislation for Manufacturing Pharmacy and regulatory processes