qa compliance manager, responsible person deputy in Bulle

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

job details

posted
location
bulle, fribourg
sector
Life Sciences
job type
permanent
reference number
10116
contact
coralyne saint-cirel, geneva professionals health care & life sciences
phone
058 201 54 40
apply now

job description

Your main mission is to manage the team “QA Compliance Pharma” reporting to Quality Assurance & Regulatory Compliance (QARC) head, fostering a quality culture with manufacturing, other operations and with suppliers or other external partners, to ensure availability and quality of treatments for our patients.

 

Your main responsabilities:

 

  • Responsible for quality oversight of end to end operations of Active principle ingredients and oral solid forms in compliance with Quality policies and systems aligned on current GMP and relevant requirements from Health Authorities.
  • Responsible to proactively support operations to identify, develop, and implement quality and operational excellence improvements in response to business requirements and/or technical changes and/or regulatory requirements.
  • Responsible Person's Deputy in compliance with Swiss legislation 
  • Responsible for Regulatory Compliance to any relevant operational activities in line with the business requirements and/or changes and/or regulatory requirements.

Profile

  • Graduated in Pharmacy or equivalence in experience
  • Minimum 5 years of experience in Quality Assurance Operations in the areas of Active Pharmaceutical Ingredients and oral solid forms
  • Minimum 1 year of experience as Responsible Person (or equivalent)
  • Experience in investigation (ex. Kepner Tregoe methodology), and operation excellence (lean. 6 sigma).
  • Experience in preparing and participating to inspections conducted by Swiss and foreign authorities
  • Proven successful experience in coordinating multifaceted projects
  • Oral and written communications in both French and English and mastering of specific regulatory language. 

     

To succeed in this challenging position, you need to show strong team leadership, with ability to drive quality culture and ability to stimulate aspiration to excellence.

As Quality Professional, you are also recognized for your strong sense of observation, strong listening skills with the ability to synthesis and simplify, conjugated with common sense and coherent logic thinking.