Senior Quality Assurance Professional

2 weeks ago

Singapore beBeeQuality Assurance Full time

About Us

PQE Group is a world leader in the Pharmaceutical and Medical Device industries. Our company has been at the forefront of these fields since 1998, with over 40 subsidiaries and more than 2000 employees across Europe, Asia, and the Americas.

We are looking for a professional to support our projects in Singapore. This role will involve working closely with our team to ensure strict adherence to company procedures and regulatory requirements.

Key Responsibilities

  • Oversee routine quality control activities for on-site GMP production and testing.
  • Provide quality oversight for validation and re-qualification activities.
  • Review and approve all Qualification and Validation protocols and reports.
  • E nsure data integrity and compliance of all documentation and electronic data with applicable regulations and SOPs.
  • Support the establishment and maintenance of an effective Quality System across all GMP processes.
  • Participate in site operational readiness programs, including self-inspections and data integrity surveillance for GMP and client audits.
  • Manage quality events such as deviations, change controls, CAPAs, and laboratory investigations.

Requirements

  • Bachelor's degree or higher in Biologics, Pharmacy, Pharmaceutical Engineering, Bioengineering, or a related field.
  • 3–5 years of relevant QA experience in the biopharma or pharmaceutical industry.
  • Strong knowledge of FDA, EMA, and PIC/S GMP requirements.
  • Familiarity with biological product manufacturing and related quality control processes.
  • Previous experience with biopharma commercial supply is preferred.
  • Experience in new site start-up activities is a plus.
  • Strong proficiency in English (listening, speaking, reading, writing).
  • Skilled in Microsoft Word, Excel, and PowerPoint.
  • Excellent cross-functional communication and collaboration skills.
  • Strong logical thinking, ownership, and conflict management abilities.

Benefits

Our company offers a challenging, multicultural environment that values collaboration and innovation. As a member of our team, you will have the opportunity to work on international projects, improve your skills, and interact with colleagues from all corners of the world.

We are committed to helping our employees grow and develop their careers. If you are looking for a rewarding and exciting career, we invite you to join us.

Next Steps

If you meet the requirements for this role, please submit your application. We will review your qualifications and contact you for an initial interview if there is a match.

Thank you for considering PQE Group as your next career step

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