Packaging Quality Manager

GenèveTemporaireChimie, Pharma, Biotechnologie2019-01-28Master / Université
We are recruiting on behalf of our client a Packaging Quality Manager for a mandate.

Packaging Quality Manager

Your Responsibilities

Management of Packaging Quality Assurance in the Manufacturing Site
Batch review
  • Review batch records (production and packaging)
  • Review of Syringes sub-contractor batch
Improve, maintain and assure a continuous improvement of the following local Quality Systems to assure the quality of the product:
  • QA oversight of packaging and production area
  • Manage deviations related to packaging area and participate to investigations related to production and QC with the concerned functions
  • Follow up of PQI (Potential Quality Incident),
  • Participate in complaints investigation and Trackwise approval
  • Review/approve for issuance of GMP documents related to packaging area (SOP's, specifications, protocols, reports..)
  • Review and approve validation/qualification documentation related to packaging - ea
  • Ensure that activities related to the quality in packaging are conform with the company policies and Corporate Quality directives
  • Participate in Risk analysis in collaboration with supportive department.
  • Manage templates/specifications in LIMS and assure their update
  • Establish compilations and trending of GMP data
  • Auditor in self-inspections and external audits
  • Participate as QA representative to projects related to packaging area.
  • Manage for her responsability area regulatory inspection
  • Perform audit trail review of GMP systems.
  • Evaluate any signal detection which could have a potential product quality impact
  • Diligently report to head of Quality Unit any Quality Alert/issue and actively participate to resolve significant Quality issues when they arise
  • Assure a communication flow and collaboration with Operations and other functions to assure a product life-cycle quality
  • Indirect management of investigation teams and risk analysis team
  • backup for quality documentation management and issuance of batch record
  • backup in production deviation management and complaints management

Your Profile

  • University degree in Pharmacy, Chemistry or Master degree in Quality Assurance, Quality Control and Validation method
  • Fluency in English
  • Quality commitment, flexibility, initiative, problem solving, team working, cross functional cooperation behaviour
  • You agree to work every Saturday with the other three working days arranged.

Votre contact

Etes-vous intéressé(e)? Vous pouvez postuler soit en ligne, soit par eMail.

Merci de préciser la référence JN -012019-294751