Qualification Specialist (all genders)
Festanstellung, Vollzeit · Hannover
Key Responsibilities and Work assignments
Activities and responsibilities
Your main tasks include:
- Plan, execute, and document qualifications (DQ, IQ, OQ, PQ) for equipment, computerized systems, and critical premises.
- Create and review qualification and calibration documents in accordance with GMP guidelines.
- Maintain and improve the procedures for qualification.
- Coordinate and supervise external service providers involved in qualification projects.
- Support risk assessments and prepare deviation and change control documentation.
- Collaborate closely with departments such as QC, CSV, IT and R&D.
- Participate in internal and external audits as well as regulatory inspections.
Your profile
Qualification profile
- Degree in a scientific, technical, or pharmaceutical field (e.g., Pharmacy, Biotechnology, Process Engineering, Chemistry).
- 5+ years of professional experience in qualification within the pharmaceutical industry (e.g., HPLC, Capillary Electrophoresis systems and cleanrooms).
- Solid knowledge of GMP regulations and relevant standards (e.g., EU GMP, US GMP, Annex 15, ICH Q9/Q10).
- Experience with analytical computerized systems and electronic inventory systems is a plus.
- Structured, independent, and solution-oriented working style.
Why us?
We offer an innovative, vibrant and multicultural environment that gives you the chance to bring in all your competencies, and together with a highly motivated team drive the change and develop personally. We believe in a culture of respect, trust, reliability and positivity.
Interested? Then please send your full application as a PDF including earliest start date and salary expectations via the application-button.
Become part of GlycoThera and grow with us!
Auf diese Stelle bewerben
About us
GlycoThera Pharmaceutical Services is a leading global service provider for contract development and analytics for biotherapeutics at all stages of product life cycle. With our expertise in the development of biologics (recombinant proteins such as monoclonal antibodies, cytokines and hormones), manufacturing sciences, analytics, quality control and regulatory strategy we support a broad range of clients globally, from emerging biotech startups to leading global pharmaceutical companies.
Auf diese Stelle bewerben
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