QA/QC Expert

For our client in BASEL we are looking for a QA/QC EXPERT for a 12-MONTH PROJECT.

DURATION: 2018-01-08 TILL 2018-12-31

WORKLOAD: 100%

LOCATION: BASEL

JOB PURPOSE:
Responsible for implementing and maintaining the ESO AS&T quality system including tools and pro-cesses. Responsible for providing technical support and problem solving on AS&T and stability aspects of the External Supply organization. The candidate is the Contact for analytical issues at the suppliers/CMOs and for stability issues associated with products.

MAJOR ACCOUNTABILITIES:

The candidate implements and supports global AS&T programs in External Supply.
Defines and implements the business processes and SOPs necessary to maintain a robust Quality System within External Supply affecting the laboratory activities (eg management of changes, maintenance of testing monographs)
Support Implementation of Guidelines at external partners and suppliers
Lead programs and initiatives to implement changes and to remediate where required
Interprets stability data, analyzes trends, and provides scientifically sound conclusions to support assignment and monitoring of product shelf life, storage conditions, packaging and transport categories. Provide corrective actions to address immerging stability issues.
Support External Suppliers Qualification process
Support Tech Transfer assessments for analytical method transfers.
Lead QC aspects of Technical meetings with the External suppliers and establish good working relationships with clear communication and defined actions and goals.
Support assessments of analytical Change Control records for acceptability. Define studies needed to support the changes.
Interacts with the External Supplier to guarantee suspect analytical results investigations are managed in agreement with the company's standards and the right CAPA is implemented.
Ensure Testing Monographs are state-of-the-art with respect to technique and technology, and in line with registration documentation. Support programs and initiatives to implement changes to, and upgrade Testing Monographs where required
Support site readiness for Health Authority inspections & participate in audits on request.
Support analytical troubleshooting as needed.

IDEAL BACKGROUND:

- University degree in Pharmacy, Biochemistry, Chemistry, or another related science
- Fluent in speaking/writing in English
- 5-8 years experience in the pharmaceutical industry
- Mind. 5 years experiences in QC, method development, validation or stability testing
- Thorough knowledge of cGMP requirements.
- Thorough knowledge of cGMP, ICH guidelines, regulatory requirements & risk management.
- Good leadership skills and experiences in leading project teams

For further information please contact Beata Arciszewska: (see below)