Quality Assurance Specialist

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 founded in 2005 and specialized in the industry. We work in the Pharma, Biotechnology, Medical Devices, Energy, Infrastructure, Transportation, Chemicals, and Information Technology sectors.

As a consultant, you will have to support our clients in the realization of their projects on site by bringing your expertise and your skills.

You are agile and eager to adapt to different work environments that will fuel your curiosity of seeing what’s behind closed doors of the biggest projects of our client’s portfolio.

Main 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

Your Profile

• Degree in Pharmacy (PharmD), Engineering, Biotechnology, or Quality Management
• Prior experience within the biotechnology or biopharmaceutical industry
• Strong understanding of biotechnological manufacturing processes, including USP, DSP, and Fill & Finish operations
• Good knowledge of cGMP regulations and quality standards
• Comfortable working in an international and cross-functional environment
• Fluency in both English and German, written and spoken, is mandatory

Thank you for your interest in this opportunity. Please note that only candidates selected for an initial interview will be contacted.