Validation and Quality Expert

3 weeks ago


Singapore MANPOWER STAFFING SERVICES (SINGAPORE) PTE LTD Full time
Quality Assurance Validator Role

As a Quality Assurance Validator at MANPOWER STAFFING SERVICES (SINGAPORE) PTE LTD, you will partner with cross-functional teams to ensure quality oversight of commissioning, qualification, and validation lifecycle activities. This includes providing quality oversight to validation/qualification and continued verification of facilities, utilities, equipment, computerized systems, decontamination, manufacturing processes, shipping, and transportation.

Responsibilities:

  1. Provide quality oversight to validation/qualification and continued verification of facilities, utilities, equipment, computerized systems, decontamination, manufacturing processes, shipping, and transportation.
  2. Support quality risk management activities, including manufacturing process risk assessments, shipping risk assessments, hold time studies, assessment of Extractables and Leachables.
  3. Collaborate with stakeholders to establish holistic control strategies to ensure appropriate process controls to eliminate and/or reduce identified quality risks.
  4. Review, evaluate, and approve CQV lifecycle documents, including user requirements specifications, validation plans, risk assessments, engineering drawings, protocols, and reports.
  5. Ensure all qualification/validation are successfully concluded, all documentation completed, and all non-conformities addressed, before systems are released for GMP use.
  6. Responsible for ensuring all CQV activities meet Sanofi's quality requirements and fulfill regulatory expectations.


Requirements:

  • Bachelor's or Master's degree in Pharmacy, Science, Engineering, or related Life Sciences or Technology fields.
  • A minimum 7-10 years of relevant experience, preferably in Validation and/or Quality in the pharmaceutical or biotechnology industry.
  • Sound knowledge and understanding of regulatory requirements and industry best practices pertaining to management of validation lifecycle.
  • Working knowledge of quality risk management methods and tools.
  • Solid technical knowledge in the use and application of risk- and science-based approaches to validation.

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