qa complaints & pqrs specialist in Aubonne

posted
contact
Lucie Milewski, Randstad Merck Aubonne
job type
temporary
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job details

posted
location
aubonne, vaud
sector
administration
job type
temporary
reference number
129085-39104
contact
lucie milewski, randstad merck aubonne
phone
058 432 61 41

job description

For a temporary position until 2023, in a biotech production site in Aubonne, we are looking for :

QA Complaints & PQRs Specialist

A proactive, flexible and analytical person who is willing to adopt to changes positively, find constructive solutions, and can represent Aubonne Quality as Responsible for Complaints management.

Your main responsibilities will be to ensure that all technical complaints assigned to Aubonne site are managed according to any applicable internal and external regulations and are in compliance with current Good Manufacturing Practices (cGMP's), any applicable regulatory filings and quality standards.

For this purpose you will treat customer complaints and coordinate investigations (internally or externally) to ensure that preventive and/or corrective actions are implemented as appropriate. You will manage reception and destruction of complaint samples. You will prepare monthly/ Yearly complaint review reports and you will be accountable for the complaints aspects during health authorities' inspections.

You are also responsible for Product Quality Review compilation in collaboration with concerned departments on site. You ensure that a thorough review is performed in line with the established planning and that corrective/preventive actions are taken when appropriate. As owner of the system, and you will be accountable for the product quality review aspects during health authorities' inspections

As a member of the Quality Assurance Team, you will play important role in ensuring patient safety and driving process efficiencies through quality improvements.

qualification

Who you are

· University degree in a life science discipline (Pharmacy, Biology,Quality)

· Min 5 years' experience in pharmaceutical industry (production and/or quality department)

· Familiar with GMP- and International Conference on Harmonization (ICH) -regulations

· Ideally 2-3 years' experience in production, Quality control or QA release

· Fluent in French and English

  • Knowledge of IT applications, e.g. MS Office and ideally SAP/ Trackwise

Are you interested ? Please apply!