Senior Validation Manager

5 days ago


Port Elizabeth, Eastern Cape, South Africa Aspen Pharma Group Full time

Job Summary:

We are seeking an experienced Senior Validation Manager to join our team at Aspen Pharma Group. The successful candidate will be responsible for leading the validation process, ensuring compliance with regulatory requirements, and providing technical support to production teams.

Key Responsibilities:
  • Validation Planning and Execution
    • Develop and implement validation plans to ensure compliance with regulatory requirements.
    • C coordinate validation activities with quality control and production teams.
    • Evaluate risk from executed validation protocols.
  • Qualification and Requalification
    • Coordinate qualification activities with quality control and production teams.
    • Compile, implement, and perform relevant qualification protocols as per SOP.
  • Regulatory Compliance
    • Review accuracy and integrity of protocols, reports, and documentation generated comply with regulation.
    • Review compliance of validation documentation with QMS.

Requirements:

  • Certification/Diploma and a minimum of 5 years of related experience.
  • Hold a degree or equivalent qualification in Science (Chemistry, Microbiology) or Engineering (Chemical, Pharmaceutical or Process), or equivalent industry experience.
  • Supervisory/Management experience.


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