QA Expert Senior

  • Salary: Competitive
  • REF Number: 54477198
  • Consultant: Adrien Guimard
  • Contact: +41 (0) 800 106106
  • Date Published: 02.10.2024
  • Industry: Pharmaceutical
  • Location: Neuchâtel, Switzerland
  • Functional Expertise: Quality Assurance

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. 

Apply for this job

We'll store this in session so if you're applying for multiple jobs today so you can use this as a base.