Biotech QA Engineer — GMP, QMS, Audits

agap2 Switzerland; Basel; On-site; CHF 60,000 - 90,000; Full time

Job summary

agap2 Switzerland is seeking a consultant to support our clients on site, ensuring QMS maintenance and continuous improvement. The role involves drafting GMP docs, reviewing batch records, and overseeing QA activities across CMOs and subcontractors.

You will work in an international, cross-functional environment, requiring strong GMP knowledge, biotech manufacturing understanding, and fluent English and German communication. This position is based in Basel, Switzerland.

Qualifications

• Degree in Pharmacy, Engineering, Biotechnology, or Quality Management.
• Experience in biotechnology or biopharmaceutical industry.
• Understanding of USP, DSP, and Fill & Finish processes.
• Fluency in English and German (written and spoken) mandatory.

Responsibilities

• Ensure the maintenance and continuous improvement of the Quality Management System (QMS).
• Prepare batch release documentation, including detailed review of batch records.
• Draft, review, and approve GMP-related documentation.
• Review and approve biotechnology process validation documentation (validation plans, protocols, and reports).
• Manage quality events and systems such as Change Controls, Deviations, CAPA, OOS investigations, and customer complaints.
• Oversee quality activities related to subcontractors and CMOs, including qualification and performance monitoring.
• Develop, update, and maintain quality procedures and SOPs.
• Prepare Annual Product Quality Reviews (APQRs).
• Conduct internal audits and provide support during regulatory inspections.

Skills

GMP knowledge

Cross-functional

Biotech manufacturing

Bilingual EN/DE

Education

PharmD

Engineering

Biotechnology

Quality Management

Tools

QMS

CAPA system

Job description

agap2 Switzerland is seeking a consultant to support our clients on site, ensuring QMS maintenance and continuous improvement. The role involves drafting GMP docs, reviewing batch records, and overseeing QA activities across CMOs and subcontractors.

You will work in an international, cross-functional environment, requiring strong GMP knowledge, biotech manufacturing understanding, and fluent English and German communication. This position is based in Basel, Switzerland.