Share this Job

Site Head of Quality f/m

 

Your role :

 

As the Head of Quality, you will ensure the respect of Quality Systems & processes as required by current GMP. You will organize and supervise pharmaceutical operations and assure permanent compliance with the French Public Health code by delegation of the Responsible Pharmacist.

As a manager of the Quality Assurance and Quality Control departments you ensure the creation/update and monitoring of harmonized systems between departments.

You represent Semoy site in the relations with the authorities during inspections (Ansm, FDA, MHLW JP, Anvisa...), during audits (internal quality and external customers when acting as a CMO) and decline the Group Quality objectives in the site.

You also supervise and/or prepare annual assessments for applicants (Site Master File, Registration...).

With your team (approx 80p in total) you manage the analysis and treatment of Customer complaints, the implementation of annual validation plans and audits. You monitor regulatory aspects, guarantee the compliance of Drug Products according to Marketing Authorization Dossier, supervise the release or rejection of batches process and detect non-compliance risks by implementing preventive actions.

 

Please submit your application in English.

 

Who you are :

 

  • Pharmacist with previous experience of min 10 years as Responsible Pharmacist or Delegated Pharmacist on a manufacturing site
  • Work experience in pharmaceutical or chemical industry required
  • Demonstrated ability to manage multi-disciplinary teams in an international and matrix company
  • Strong experience in implementing and maintaining Quality excellence processes and operational actions in a production site(s)
  • Fluency in English is mandatory
Job Requisition ID:  187841
Location:  Centre - all
Career Level:  E - Professional (10+ years)
Working time model:  full-time


Job Segment: Pharmaceutical, Public Health, QC, Quality, Science, Customer Service, Healthcare

Apply now »