Gmp QA Coordinator
vor 2 Wochen
**GMP QA Coordinator (5239 - ADA)**
Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking for a **GMP Quality Assurance Coordinator** to join their Global Pharmaceutical Development Team. It is a **12-month contract**, with potential extension, based in **Basel**.
**Main Responsibilities**:
- eQMS Activities:
- Management of Veeva, Reports, Binders etc.
- Preparation of reports for trending and monitoring of Change Controls, Deviations, CAPA, OOS/OOE
- Management of QA related Documents in Veeva
- Write, review, and/or approve internal SOP’s and other, according to employee’s expertise
- Managing archiving of paper-based documentation for the QA Department
- Other administrative task, e.g. preparative work for internal Audits, Inspections from Health Authorities, Quality trending, conduction of trainings (e.g. Quality modules, GxP training etc.)
- Support stakeholders within Veeva activities/issues
- Support for Supplier qualification, Quality agreements issuance and/or process validation activities where needed
- Write, review, and/or approve internal SOPs governing compliance related operations and other GMP/GDP and regulatory related documentation
- Assist for the preparation of SAP Master Data, release transactions, extension of shelf life, etc
- Promote GxP and Quality mindset at all levels within the organization
**Qualifications and Experience**:
- ** Relevant Swiss working/residency permit or Swiss/EU-Citizenship required;**:
- Apprenticeship, college or university degree in Pharmacy, Chemistry or alternative technical/science
- Minimum 3 years experience in **Quality** and/or Pharmaceutical industry
- Knowledge and understanding of basics in drug product development, manufacturing processes, as well as quality control, packaging and distribution aspects
- Knowledge of relevant **GMP/GDP** and/or international quality regulations e.g. ICH, ISO, WHO, PIC, FDA, EU GMP Guide (EudraLex Vol. 4), EU GDP
- Ability to work on multiple projects with various disciplines and prioritize workloads according to the project importance
- Attention to detail, organization, multi-tasking, and comfort interacting with people who might be junior or senior to the incumbent
- Ability to pro-actively notice, report, and work on quality gaps and improvements
- Ability to independently perform assigned tasks within given timelines. Timely communication of any anticipated delays to meet given timelines
- Fluent verbal and written communication skills in English and at least basic knowledge of an additional European language e.g. German or French
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