R&D Quality Specialist (m/f/d)
Job description :
Support the supervisor in the timely release of GMP relevant documents. Support departmental research & development projects and objectives according to agreed timelines and standards in the given area of compe-tency and support adherence to compliance with GMP in TRD.
- Perform review of GMP relevant documents for compliance with SOPs (e.g. review of analytical raw data and analytical documents).
- Clarify simple deficiencies in GMP documents with the line unit experts in own responsibility.
- Recognize complex deficiencies in GMP documents, report them to supervisor, suggest actions and supervise agreed follow-up.
- Write and complete GMP relevant documents in own area of responsibility (e.g CoAs, BRR sheets).
- File and archive documents owned by QA
- Collaborate with other associates to support the service function of QA
- Participate in knowledge exchange in TRD
- Participate in training of new and temporary employees
- Technician background (chemistry, analytics, biologics). Bachelor or other university degree with focus on analytics is preferred but not mandatory.
- The right candidate should have been working in Quality Assurance or Quality Control already, and in a regulated environment (GMP) in other pharmaceutical companies.
- Very good English and German communication skills
- Basic financial knowledge (e.g., cost management, budget forecast, etc.)
- Maintain sound working relationships with partners and customers
- Long-term temporary employment with an option to extend
- The chance to get involved in one of the most successful pharmaceutical companies in the world
- Fair, contemporary and punctual remuneration
- A partner at your side who focuses on honesty and quality
If you would like an insight into the detailed job description, we look forward to receiving your complete application documents by e-mail to Ms Nadine Rutz (firstname.lastname@example.org).
Forschung Entwicklung Chemie Pharma Basel Vollzeit