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