Biotech QA Specialist — GMP, QMS & Compliance Expert

agap2 Switzerland; Basel; Vor Ort; CHF 110.000 - 160.000; Teilzeit

Zusammenfassung

agap2 is a European engineering and operational consulting group, seeking a consultant to support client projects on site with QA/QMS expertise in biotech/pharma. You will ensure QMS maintenance, draft and review GMP docs, and oversee audits and CAPA across international teams.

Ideal candidates hold a PharmD or related degree, with experience in biotechnology or biopharmaceuticals, and fluent English and German.

Qualifikationen

• Degree in Pharmacy (PharmD), Engineering, Biotechnology, or Quality Management.
• Prior experience in biotechnology or biopharmaceutical industry.
• Strong understanding of biotechnological manufacturing processes (USP, DSP, Fill & Finish).
• Knowledge of cGMP regulations and quality standards.
• Ability to work in an international cross-functional environment.
• Fluency in English and German, written and spoken.

Aufgaben

• 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.

Kenntnisse

QMS

Batch release

GMP

Audits

CAPA

OOS investigations

CMOs

SOPs

APQRs

Process validation

Ausbildung

PharmD

Engineering

Biotechnology

Quality Management

Jobbeschreibung

agap2 is a European engineering and operational consulting group, seeking a consultant to support client projects on site with QA/QMS expertise in biotech/pharma. You will ensure QMS maintenance, draft and review GMP docs, and oversee audits and CAPA across international teams.

Ideal candidates hold a PharmD or related degree, with experience in biotechnology or biopharmaceuticals, and fluent English and German.