QA Products
vor 1 Woche
ROLE OVERVIEW
RESPONSIBILITIES:
- Act as QA point of contact in the CMC team to support GMP compliance for internal and external manufacturing of IMP products used in Phase I / II clinical trials.
- Shop floor support (Quality Oversight of the inhouse manufacturing and testing of Bulk Drug Substance, solve issues in real time with operations personnel, etc.)
- Act as QA counterpart for External manufacturing, fill & finishing operations and label and packaging of IMPs
- Performs independent quality evaluation of investigational reports including root cause analysis cause/preventive action identification, CAPA effectiveness check and trending.
- Reviews and approves deviations, CAPA's, change controls, Quality Control LIR/OOS.
- Coordinates and performs batch record disposition for manufactured products for Phase I / II clinical trials support.
- Responsible for compliance review and approval of the following records: batch records/formulation records, release and stability data, method qualification/validation reports, stability protocols, product specification sheets, M/WCB records, IND/IMPD and development reports, etc.
- Participates in Raw Material management (specifications definitions, shipping conditions, deviation, etc),
- Lead and assist in continuous improvement projects as assigned interacts with Team Leader, peers, internal customers, external clients, and other cross functional peers to gain alignment on sound quality decisions.
- Provide cGMP and associated training to QA and other departments to improve, Quality awareness and compliance.
EDUCATION AND DESIRED EXPERIENCE:
- Master's degree or equivalent in life sciences
- Quality professional with minimum 58 years of handson experience in a QA cGMP regulated environment within Biopharmaceuticals or equivalent.
- Knowledge of US, EU, PIC/s cGMP guidelines
- Manufacturing USP, DSP and/or Quality Control experience is a plus.
- Experience with Quality Systems to include, Batch Record design/review and supporting investigations.
- Good organization skills and attention to detail, with strong verbal and written communication skills.
- Proven ability to identify quality issues/discrepancies and effectively and proactively resolve the issues/discrepancies in a flexible and constructive manner.
- Fluent English is required, French is highly desirable
LOCATION:
You will join us, in a picturesque city of La Chaux-de-Fonds, Neuchâtel, Switzerland.
This is a rare opportunity to join our growing scientific team at the very start of something special. You will become a part of the foundation of a new company imprint
Business Unit:
Quality Unit
Type of Contract:
Full time
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