Quality Assurance Specialist

Key Responsibilities:

• Develop, implement, and manage the site quality management system (QMS) in line with global cGMP requirements.
• Oversee quality aspects during facility construction, equipment installation, commissioning, and qualification.
• Provide QA oversight for validation protocols (DQ, IQ, OQ, PQ), technology transfer, and process qualification.
• Lead the preparation and review of SOPs, quality manuals, batch records, and validation documentation.
• Coordinate with engineering and project management teams to ensure compliance with design and construction quality standards.
• Ensure quality alignment with procedures for material management, manufacturing, utilities, and laboratories.
• QA personnel in preparation for facility operational readiness.
• Internal audits and support external audits or inspections by regulatory authorities (SFDA, WHO, etc.).
• Establish systems for deviation management, CAPA, change control, and document control.
• Participate in supplier qualification and quality agreement management.
• Support product licensing and WHO prequalification documentation.

Responsibilities

• Develop, implement, and manage the site quality management system (QMS) in line with global cGMP requirements.
• Oversee quality aspects during facility construction, equipment installation, commissioning, and qualification.
• Provide QA oversight for validation protocols (DQ, IQ, OQ, PQ), technology transfer, and process qualification.
• Lead the preparation and review of SOPs, quality manuals, batch records, and validation documentation.
• Coordinate with engineering and project management teams to ensure compliance with design and construction quality standards.
• Ensure quality alignment with procedures for material management, manufacturing, utilities, and laboratories.
• QA personnel in preparation for facility operational readiness.
• Internal audits and support external audits or inspections by regulatory authorities (SFDA, WHO, etc.).
• Establish systems for deviation management, CAPA, change control, and document control.
• Participate in supplier qualification and quality agreement management.
• Support product licensing and WHO prequalification documentation.

Qualifications

• Bachelor’s or Master’s degree in Pharmacy, Biotechnology, Microbiology, Chemistry, or related discipline.
• Minimum 3 years of QA experience in biopharmaceutical or vaccine manufacturing.
• Strong knowledge of cGMP, WHO TRS, ICH Q-series guidelines, and regulatory expectations for vaccine manufacturing.
• Proven experience in greenfield or technology transfer projects (vaccine or biological manufacturing preferred).
• Experience in establishing and qualifying cleanrooms, utilities (WFI, HVAC, etc.), and analytical/QC laboratories.
• Familiarity with electronic quality management systems (eQMS) and data integrity principles.

Pay range and compensation package

8000SR