Quality Assurance Specialist – Pharmaceutical Manufacturing

About the role

PSC Biotech is seeking an experienced Quality Assurance Specialist to provide QA oversight for its pharmaceutical manufacturing clients. You will act as a key quality representative, ensuring compliance with global regulatory standards while supporting a range of manufacturing and validation activities.

Key responsibilities

• Ensure adherence to FDA, EMA, ICH, cGMP and internal quality standards.
• Provide QA support for aseptic manufacturing, sterile processing, and biologics production.
• Review and approve quality documents such as deviations, CAPAs, change controls, investigations, risk assessments and validation records.
• Assess manufacturing records, batch documentation and quality events for regulatory compliance.
• Support internal and external audits, supplier audits, regulatory inspections and QMS activities.
• Partner with manufacturing, QC, engineering and regulatory affairs teams to drive quality initiatives and mitigate compliance risks.
• Provide governance throughout the engineering project lifecycle, reviewing commissioning, qualification and validation deliverables.

Required profile

• Strong verbal and written English communication skills.
• Proven experience in pharmaceutical or biotech quality assurance.
• Ability to work collaboratively across multi‑disciplinary teams.

Required skills

• GMP and cGMP knowledge.
• Familiarity with FDA, EMA and ICH regulations.
• Aseptic manufacturing and sterile processing expertise.
• Biologics production experience.
• Validation documentation and risk assessment skills.