Senior Quality Assurance Specialist

KPC International - Excellence from Concept to Completion

KPC International began operations in 2001, our team of Engineers and Scientists have helped our clients achieve project success all over the world within the pharmaceutical and biopharmaceutical space.

We specialise in Plant Facility Start-Up from Strategy and Planning to Execution, through to Operational Readiness. We are proud to support our clients in delivering their life-changing products to patients.

Senior QA Specialist – Sterile Manufacturing (Stein)

We’re seeking a Quality Assurance professional to support sterile manufacturing operations, ensuring cGMP compliance and driving quality improvements across projects.

Key Responsibilities:

• Serve as QA single point of contact for assigned activities.
• Author, review, and approve SOPs, risk assessments, WI, and other deliverables.
• Oversee quality records: deviations, CAPAs, change controls, and validations.
• Support investigations, root cause analysis, and corrective actions.
• Participate in projects and lead lean improvements to enhance efficiency.
• Liaise with external partners and authorities, support audits and inspections.
• Define and report on Quality KPIs and maintain Quality Oversight in manufacturing.
• Mentor team members and deputise Team Lead QA Operations.

Qualifications:

• Master’s or PhD in Chemistry, Biology, Pharmacy, or related field.
• 5–10 years QA/QC experience in pharmaceutical manufacturing.
• Strong cGMP knowledge, regulatory compliance expertise.
• Excellent problem-solving, planning, and communication skills. English required; German a plus.

Join us to ensure the highest quality standards and contribute to the success of our Drug Product network.

KPC -International offers an inclusive environment where you can broaden your experience, perspective and skills to help make an impact on the lives of others.

KPC – International is an Equal Opportunity Employer.