Operation Quality Manager

Posted 20 Lundi juin
Type d'offre Permanent
secteurLife Sciences

Job description

For its pharmaceutical partner, Kelly Life Sciences is looking for:

Operation Quality Manager

(Permanent position)

Your mission

Management of Operation Quality Assurance in the Geneva Manufacturing Site

Your responsibilities

  • Release incoming raw materials and consumables
  • Review batch records (production and packaging)
  • Assure the Technical Release of the semi-finished and finished product in compliance to applicable regulations, regulatory dossiers and product specifications.
  • Manage all deviations (production, packaging and QC)
  • Manage complaints investigation
  • Review/approve for issuance of GMP documents related to production area (SOP's, specifications protocols, reports..), preventive maintenance plan and SOPs and validation/qualification documentation related to production area
  • Ensure that activities related to the product quality and sterile operation quality are conform with the company policies and Corporate Quality directives
  • Main contact for this area during regulatory inspections
  • Coordinate cleaning activities with external contractor
  • Establish compilations and trending of GMP data
  • Could be Lead auditor in self-inspections and external audits
  • Direct management of operation and packaging QA team

Your profile

  • University degree in Pharmacy, Chemistry or Biochemistry
  • 5 to 10 years' experience in GMP environment inspected by FDA, Swiss and other Health Authorities
  • Fluency in English (both oral and written)
  • Quality commitment, flexibility, initiative, problem solving, team working, cross functional cooperation behaviour

Your contact at Kelly:
Anaïs Mieszczak
Consultant Professional Staffing
Kelly Life Sciences