qa manager fr-en-de in Fribourg

posted
contact
Coralyne Saint-Cirel, Geneva Professionals Health Care & Life Sciences
job type
permanent
apply now

job details

posted
location
fribourg
sector
Life Sciences
job type
permanent
reference number
11968
contact
coralyne saint-cirel, geneva professionals health care & life sciences
phone
058 201 54 40
apply now

job description

Your main tasks:

- Support the local Swiss Affiliate QA organization to implement, maintain and upgrade the local Quality Management System (QMS) in order to ensure that compliance is maintained for all cGXP with local/International regulatory requirements and global SOPs

- Prepare documents and perform activities towards tasks and processes such as Batch Release, Customer Authorization, Complaints, Returns, Risk Assessments, Deviations and Change control

- Ensure the reference documents for batch release for Swiss market are available and up-to-date

- Conduct Product Quality Reviews (PQR) of the products in compliance with local legislation in collaboration with Deputy RP

- Devolop and maintain Database of GMP certificates and Audit reports for all products on Swiss market

- Participate actively in the completion of CAPAs and support the implementation of Global projects at the Swiss Affiliate

- Support audits, self-inspections and contribute to Vendor Management and oversight of vendors

- Develop and/or manage documents of the QMS

- Ensure relevant documents are maintained in the appropriate tool if/as required, and critical records archived, retained and destroyed

 

Profile: 

- Pharmacist or other scientific background (Master)

- 5 years min. experience, ideally in a similar function in QA or GMP

- French or German mother tongue (with good knowledge of the other language), fluent English

- TrackWise, Auditing or Vendor management expertise would be an advantage.

- The possibility of including the function of Deputy RP will be considered. Any previous experience as RP or Deputy RP would be an advantage.