GlycoThera Pharmaceutical Services has been successfully providing analytical services for more than 20 years. Our clients are leading pharmaceutical companies specializing in biologics and biosimilars. Our comprehensive analytical service covers all phases of the product life cycle, from laboratory-scale development to market approval and batch release. Our strengths lie in method development, product characterization, validation and release and stability testing. We work according to the highest GMP standards and ICH guidelines to ensure that our customers meet regulatory requirements. With our many years of experience and expertise, we support our customers in meeting the highest quality standards and successfully bringing their products to market.
To expand our team, we are seeking a highly motivated Qualification Specialist for the GMP laboratories in Hannover and Jülich. This position is part of the Quality Department and based in Hannover.
Qualification Specialist (m/f/d)
(full-time, permanent) 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.
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.
Ability to thrive in a dynamic and interdisciplinary environment.
Excellent written and spoken English; German is a plus.
You are a smart, proactive and solution-driven scientist with a hands-on attitude who is able to independently progress projects, prioritize tasks adequately and work against tight timelines. At the same time you maintain a high quality standard in your work, support the team and foster a sense of positivity. The team´s success is your success.
Language: English, German is highly beneficial.
Work Experience: Industrial work experience (biotechnology/biopharma) is highly appreciated. Our Hannover-based laboratories with currently 30 employees 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.