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Quality Assurance Specialist

3 weeks ago

Singapore RECRUIT EXPRESS PTE LTD Full time
Job Description:

We are seeking a highly skilled Quality Assurance Specialist to join our team at Recruit Express Pte Ltd.

About the Role:
  • Support Validation Projects: Assist with qualification and validation activities, ensuring compliance with regulatory requirements.
  • Review and Approve Documents: Review and approve validation documents like protocols, reports, and procedures.
  • Manage Discrepancies: Identify and address issues in validation protocols, ensuring corrective actions are documented.

The ideal candidate will have a strong understanding of FDA/EU cGMP requirements, including CFR 21 Part 11, and familiarity with PDA and ISPE GAMP guidelines.

Key Responsibilities:
  1. Qualification and Validation Activities: Assist with qualification and validation of equipment, processes, cleaning, and computer systems.
  2. Document Review and Approval: Review and approve validation documents, ensuring they meet regulatory requirements.
  3. Discrepancy Management: Identify and address issues in validation protocols, ensuring corrective actions are documented.
Requirements:
  • Bachelor's degree in Pharmaceutical Sciences, Life Sciences, Biology, Biotechnology, Chemistry, Chemical Engineering, or related field.
  • At least 2-3 years of experience in quality assurance, manufacturing operations, or validation in the pharmaceutical or biotechnology industry.