Quality Assurance Engineer

Role Overview:

The Engineer Quality Assurance (Equipment Qualification) will be responsible for executing and managing qualification activities (IQ/OQ/PQ/FAT/SAT) for biopharmaceutical equipment and systems in alignment with GMP, GEP, and GAMP standards. The incumbent will act as a key liaison between internal teams and customers during Factory and Site Acceptance Tests, ensuring adherence to regulatory, technical, and quality compliance requirements.

Main Responsibilities & Tasks:

• Lead and execute equipment qualification activities including

  (IQ), (OQ), and (PQ)

  .
• Manage

  PRE-FAT, FAT, and SAT

  activities in line with approved test protocols and ensure compliance with specifications and documentation standards.
• Coordinate and conduct

  internal audits, risk assessments, and deviation reviews

  to ensure ongoing compliance with Quality Management Systems.
• Collaborate with

  cross-functional teams

  (Engineering, Operations, Project, and Regulatory) to troubleshoot and resolve quality and technical issues.
• Ensure

  Quality Management practices

  are effectively implemented and monitored across qualification and testing processes.
• Review and approve qualification protocols, test results, and associated documentation in compliance with internal and regulatory standards.
  
• Interface with

  customers during FATs and SATs

  , providing technical clarification and ensuring satisfaction through professional engagement.
• Maintain proper documentation, control of non-conformances (NCRs), and timely closure of CAPAs.
  
• Support continuous improvement initiatives, promoting adherence to

  GMP, GEP, GAMP, and ISPE

  standards.
• Train and mentor quality team members in qualification best practices and compliance procedures.
  

Qualifications & Skills:

• Bachelor’s Degree in Biotechnology or Chemical Engineering

  (mandatory).

• 3–5 years of hands-on experience

  in

  equipment qualification and commissioning

  within the

  biopharmaceutical or pharmaceutical industry

  .
• Proven expertise in executing

  IQ, OQ, FAT, and SAT

  for process equipment and systems.
• Strong understanding of

  GMP, GEP, GAMP, ISPE

  , and related regulatory frameworks.
• Demonstrated ability to work

  independently

  with minimal supervision, managing priorities and deliverables effectively.
• Excellent

  communication, coordination, and customer-facing skills

  to handle client FATs and project discussions confidently.
• Analytical mindset with

  problem-solving abilities

  and attention to detail.
• Proficient in MS Office and documentation systems.
  
• Fluency in

  English

  (written and verbal) is essential; local language proficiency is an added advantage.

Preferred Attributes:

• Experience working directly with

  biopharma clients or equipment vendors

  .
• Strong planning and organizational capabilities with a focus on quality and compliance.
  
• Ability to balance multiple qualification projects in a fast-paced environment.