Quality Assurance Specialist – Pharmaceutical Manufacturing

About the role

PSC Biotech is seeking an experienced Quality Assurance Specialist to provide QA oversight for pharmaceutical manufacturing clients. The role ensures compliance with GMP, FDA, EMA, ICH and internal standards while supporting manufacturing, validation and engineering projects.

Key responsibilities

• Ensure compliance with FDA, EMA, ICH, cGMP and company quality standards.
• Provide QA oversight 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 quality management system activities.
• Collaborate with manufacturing, technical operations, QC and regulatory affairs to drive quality initiatives and mitigate compliance risks.
• Provide quality governance throughout engineering project lifecycles, ensuring GMP, validation and quality requirements are met.
• Review and approve commissioning, qualification, validation and engineering deliverables.

Required profile

• Strong verbal and written English communication skills.
• Experience in pharmaceutical or biotech quality assurance environments.
• Ability to work with cross‑functional teams and manage multiple compliance activities.

Required skills

• Knowledge of GMP and cGMP regulations.
• Familiarity with FDA, EMA and ICH guidelines.
• Experience with aseptic manufacturing, sterile processing and biologics production.
• Proficiency in document control, deviation handling, CAPA and change control processes.
• Understanding of risk assessment and validation methodologies.