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.