(Senior) Manager Quality Operations & GDP Deputy RP
Proclinical are partnering with a biotech organisation who are currently recruiting for an individual to join their team. This role is on a contract basis and is located in wither Switzerland or France. The opening position available is for a (Senior) Manager Quality Operations & GDP Deputy RP.
- Supervise quality systems for trends and give notice to management of events needing immediate action.
- Handle events, changes, CAPAs mediating with the pertinent functions of the business unit, production units and suppliers.
- Assist with the tech transfer, such as DS and SP for biosimilars, as well as analytical method transfer and offer quality oversight for GMP compliant implementation.
- Offer quality assistance guaranteeing smooth transition from development to commercial.
- Gather key quality/compliance indicators for periodic evaluation of local quality management systems.
- Other duties may be assigned to this role.
Key Skills and Requirements:
- Educated to a degree level in a technical, engineering or similar discipline.
- Demonstrable experience within a quality function with increasing levels of accountability within a biotech, life science or pharmaceutical organisation.
- Comprehension of quality standards, for example: ISO 9001, ISO 13485, ICH Q8, ICH Q9 & ICH Q10, etc., cGMP & GDP needs for Pharmaceuticals and Combination Products, which involves Biologic Products.
- Comprehension of GMPs and best quality practices concerning biotech manufacturing procedures.
- Familiarity with regulatory agencies, for example: FDA, EMA, etc.
- Exhibited background within third-party's quality management.
If you are having difficulty in applying or if you have any questions, please contact Ayesha Kippie at +41 615 687 995
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.