QA qualification engineer

TN Switzerland; Basel; Vor Ort; CHF 80’000 - 120’000; Vollzeit

Zusammenfassung

An established industry player is seeking a skilled consultant to enhance project execution in the pharmaceutical and biotech sectors. This role involves reviewing and approving protocols, ensuring compliance with industry regulations, and providing essential technical guidance to project teams. The successful candidate will thrive in dynamic environments and contribute to significant client projects. Join a forward-thinking company that values expertise and adaptability, and be part of a team that drives innovation and quality in the industry.

Qualifikationen

• 3+ years of experience in quality assurance for pharma, biotech, or medtech.
• Master's degree in a related field is essential.

Aufgaben

• Review and approve IQOQPQ protocols and reports for QC/Production equipment.
• Ensure compliance with relevant regulations and provide technical guidance.

Kenntnisse

Quality Assurance (QA)

Regulatory Compliance (GMP, USP, Ph. Eur.)

Technical Guidance

Documentation Management

Ausbildung

Master's degree in Biotechnology

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.

Tasks

1. Reviewing and approving IQOQPQ protocols and reports for a wide range of QC/Production equipments and utilities
2. Ensuring compliance with relevant regulations (e.g., GMP, USP, Ph. Eur.)
3. Providing technical guidance and support to project teams
4. Participating in equipment qualification meetings and reviews
5. Maintaining accurate records and documentation
6. Supporting internal and external audits
7. Staying abreast of relevant industry standards and regulations

Requirements

1. Master's degree in Biotechnology or a related field
2. 3 years minimum experience in QA for qualification for pharma, biotech or medtech companies
3. Swiss or EU nationality