qa specialist fr-de-en 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
11784
contact
coralyne saint-cirel, geneva professionals health care & life sciences
phone
058 201 54 40
apply now

job description

Major Accountabilities:

- Manage and approve routine manufacturing operations: Deviations, CAPAs, Change Control, audits, Inspections support and batch record review - Maintain, develop, and collaborate to the Organization “QA Biotech” within the Quality Assurance department in alignment with the Site Vision, Mission, Long Term Plan - Responsible for compliance activities and quality strategies for projects with regards to technical operations related to manufacturing of biological actives Drug Substances in compliance with national and/or international regulations, (GMP) and relevant Quality Policies - Act as responsible Person delegate for product release - Responsible to proactively support operations (on the floor) in order to identify, develop, and implement quality and operational excellence improvements in response to business requirements and/or technical changes and/or regulatory requirements to drive and enhance site competitiveness in alignment with Quality Standards. - Maintain a quality culture in close cooperation within QA, internal partners, and external partners.

Your Profile:

- 3-5 years of experience minimum in operational production and ability to work closely with operational teams in manufacturing area - Qualified to Master degree level in life science (biology or chemical), or Pharmacist - Experience in pharmaceutical, biotechnology industry is a must  - Proven QA work experience in biotech manufacturing environment - Independent worker under tight and shifting priorities - Demonstrated understanding of the GxP environment and technical competence in core areas of Biotech product manufacturing - Languages: French and English are mandatory