Beschreibung
Quality Assurance SR. Associate - Commercial ReleaseLocation: Zug, Switzerland
Duration: 7 Months
Responsible to support Pharmaceutical Release Team activities such as:
- Batch documentation review for batch release of Pharmaceutical products: APIs, DPs and FGs, including Finished Goods sample review
- Sharing Release documentation downstream
- Support of special markets documents requirements as per MRDs
- Serialization checks for assigned products
- Overdue release classification
- Cross-functional collaboration on release related topics with internal and external stakeholders.
- Adherence to data integrity requirements
- Support local Quality System
Role requirements are:
- Minimum Bachelor's degree, Master degree preferred, in a scientific topic (Pharmacy, Chemistry, Biology, Biochemistry etc.).
- A minimum of 1-2 years of experience in similar position in pharmaceutical or biotechnology industries.
- Experience in the pharmaceutical industry (small molecules and/or biotechnology and/or aseptic filling).
- Sound knowledge of cGMP requirements, EU/FDA regulations and compliance.
- Experience in products manufacturing and/or regulatory is an asset.
- Knowledge of regulations and manufacturing is a plus.
- Strong communication skills
- Ability to work in an international matrix environment
- Negotiation skills
- Able to clearly communicate expectations to internal/external customers as well as management
- Drive new processes set up implementation and ad hoc projects
- Fluent English
- Good use of Microsoft Office Tools
- Knowledge of Oracle and Trackwise systems is a plus
Keywords: Batch, pharmaceuticals, cGMP, Commercial Release, Finished Goods, API, downstream, documentation, Quality System, biotechnology, small molecules, aseptic filling, Schweiz, Switzerland, Zug
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.