QA Associate - Stein, Schweiz - Datalynx AG
Beschreibung
For our client, a well-known pharmaceutical company in Basel, we are looking for a QA Associate (M/F/d).Background
Standard activities or routine tasks e.g. batch records reviewer, etc. Supportive project work. Support the timely release of GMP relevant documents and batches.
Support departmental projects and objectives according to agreed timelines and standards in the given area of competency and support adherence to compliance with cGMP in TRD.
General Information
**- Start date: ASAP
- Duration: 18 months
- Extension: Possible
- Workload: 100%
- Location: Basel
Taks & Responsibilities
**- Reviewing manufacturing and analytical batch records for department batches, both internal and external
- Supporting paper archiving, ensuring proper documentation and compliance
- Collaborating with team members to provide functional expertise and support departmental projects and objectives
- Writing and reviewing GMPrelevant deliverables to ensure compliance with regulatory guidelines and project quality standards
- Maintaining strict adherence to internal and external quality and safety guidelines, including cGMP regulations and SOPs
- Effectively communicating with line unit experts to address GMP and logisticrelated queries
Must Haves:
- Bachelor's degree in a technical or pharmaceutical field or in another relevant area
- 5+ years of experience as a technician in the pharmaceutical area or in a similar position
- Expertise in cGMP, as well as safety and environmental regulations and guidelines
- Basic understanding of drug development processes and regulatory requirements
- Proficiency in addressing GMP and logistic related questions with line unit experts
- Language skills: English fluent in written and spoken, German conversational
Nice to Haves
**- Pharmaceutical background
Contact:
Jan Schmitz-Elsen
Talent Acquisition Consultant
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