Pharma Quality Assurance and Compliance Specialist

5 days ago


Singapore RECRUIT EXPRESS PTE LTD Full time
Job Summary

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

About the Role

This is an exciting opportunity for a quality assurance professional to work with us in ensuring the highest standards of quality and compliance in the pharmaceutical industry. The ideal candidate will have a strong background in quality management, pharmacovigilance, and regulatory affairs.

The successful candidate will be responsible for revising and reviewing SOPs, reviewing executed MBR/EBR, supporting the manufacturing team with quality interpretations, queries, and issues, and providing quality oversight through GEMBA walks and GMP audits.

In addition, the role involves archival of QO documents, performing IQ and OQ activities, and participating in URS and design specifications.

Key Responsibilities
  1. Revising and reviewing SOPs to ensure compliance with regulatory requirements.
  2. Reviewing executed MBR/EBR to identify trends and areas for improvement.
  3. Providing quality support to the manufacturing team through regular interactions and issue resolution.
  4. Conducting quality audits and inspections to ensure adherence to GMP and regulatory requirements.
  5. Archiving QO documents and maintaining accurate records.
  6. Performing IQ and OQ activities to ensure equipment and facilities meet quality and regulatory standards.
Requirements
  • Degree in a relevant field such as pharmacy, life sciences, or a related discipline.
  • Minimum 5 years of experience in quality assurance, pharmacovigilance, or regulatory affairs.
  • Strong understanding of GMP, ISO, and regulatory requirements in the pharmaceutical industry.
  • Excellent communication and interpersonal skills.
  • Ability to work independently and as part of a team.
Benefits

We offer a competitive salary package, including:

  • An estimated salary range of SGD $80,000 - $120,000 per annum, depending on experience.
  • A comprehensive benefits package, including medical and dental coverage, retirement plan, and paid time off.
Location

This role is based in Singapore and requires relocation to our office in the city-state.

About Us

Recruit Express Pte Ltd is a leading recruitment agency specializing in the placement of professionals in the pharmaceutical and life sciences industries. We pride ourselves on delivering exceptional service and building long-term relationships with our clients and candidates.



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