We are seeking a
Quality Assurance Engineer with experience in lyophilization systems
to ensure compliance, validation, and quality excellence across equipment and processes. The role will involve working across the equipment lifecycle, including exposure to
Design Qualification (DQ)
and
Factory Acceptance Testing (FAT)
, along with core QA responsibilities.
Key Responsibilities:
Support preparation and review of qualification documents including
DQ, IQ, OQ, and PQ
Participate in
Factory Acceptance Testing (FAT)
and Site Acceptance Testing (SAT) activities
Ensure compliance with GMP, GLP, and regulatory requirements (FDA, WHO, EU)
Review batch records, SOPs, and validation documentation
Handle deviations, CAPA, and change control processes
Collaborate with Engineering, Production, and Vendors for equipment qualification and process improvement
Ensure traceability across URS, DQ, FAT, SAT, and validation lifecycle
Support audits and regulatory inspections
Maintain documentation integrity and quality standards
Required Qualifications:
Bachelor’s/Master’s in Pharmacy, Chemical Engineering, Biotechnology, or related field
3–7 years of experience in QA within pharmaceutical/biotech manufacturing
Experience with
lyophilization (freeze-drying) systems
Working knowledge of equipment qualification and validation processes
Key Skills:
Understanding of validation lifecycle (URS to PQ)
Exposure to
DQ documentation and FAT participation
Strong knowledge of GMP and quality systems
Attention to detail and documentation excellence
Good cross-functional coordination and communication skills
