QA Expert Senior
CK QLS are looking for a QA Expert, to join a Global Pharmaceutical company based in Neuchatel, for a duration of 12 months.
Hybrid: 1-2 days home office.
QA Senior expert is the Quality partner within Production Unit Team and the Quality Control laboratories, Warehouse and Engineering/Maintenance departments as applicable. You will ensure quality of information within systems and documentation in respect to current guidelines, compliance and regulatory requirements.
Responsibilities:
- Assessing results in terms of acceptability to standards, procedures and regulatory requirements.
- Reviewing and evaluate change requests/deviations according to processes, methods, quality systems and applicable regulatory files.
- Inspection and Release of raw material and external BDS.
- Ensure Release planning is up to date.
- Participate to the feeding of the KPI of release of raw materials.
- Ensure activities associated with the archiving as required.
- Acting as referent for QA expert and QA specialist.
- Coordinating the daily activities with internal and externals partners - Lead continuous improvement project.
- Acing as the Quality partner for QC Laboratory / Warehouse Department.
- Supporting for regulatory agency inspection and internal audits, closure of observations/audit items and regulatory submissions.
- Assessing the deviations in term of acceptability to standard procedures and regulatory requirements.
- Supporting all investigations related to CAPA process and complaint in the area of responsibility.
- Reviewing and evaluate internal change requests or external changes from suppliers (IFCAs) according to procedures, GMP requirements and licenses.
Candidate’s requirements:
- At least 7 years of experience in an GMP environment.
- University degree in Engineering, Biotechnology, Pharmacy, and Quality Management applied to industrial process or equivalent experience in pharmaceutical and /or biotechnological companies.
- French fluent, English read, written and spoken.
- Good knowledge of FDA, EMA, ICH regulations, Pharmacopeias and Quality system standards.
- Knowledgeable in auditing and inspection against regulatory / Quality standards.
- Knowledge/Experience with Quality tools such as Trackwise.
- Good analytical skills and ability to simplify the complex.
- Solution oriented and team spirit.
Apply:
If you are interested in the position, please send an updated CV in English at aguimard@ckqls.ch. Please quote job reference 107628 in all correspondence.
