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Operation Quality Assurance Manager

Ref: JN-062022-307542

Gepostet am 17 June 2022
Kategorie
Life Sciences

Our client is an active company in the healthcare sector based in Geneva.

Responsibilities :

  • Direct management of operations and packaging QA team.
  • 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 regulations, regulatory dossiers and product specifications.
  • Manage all deviations (production, packaging and QC) with the concerned functions.
  • Manage complaints investigations.
  • Review and 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 policies and Corporate Quality directives.
  • Coordinate cleaning activities with external contractors.
  • Establish compilations and trending of GMP data.
  • Participate in audits in self-inspections and external audits.
  • Evaluate any signal detection of potential product quality impact and participate to resolve significant quality issues.
  • Assure a communication flow and collaboration with operations and other functions to assure a product life-cycle quality.

Backup:

  • backup of QA packaging manager for QA control in packaging.
  • Backup of Packaging QA manager.
  • Backup in batch record issuance.
  • Backup in audit trail review of GMP systems.
  • Backup in due date extension for deviations and QA approval of major and critical deviations.
  • Backup for QA approval for the following QC lab documentation (lab investigation, lab equipment qualification and calibration).

Qualifications:

  • University degree in Pharmacy, Chemistry or Biochemistry with 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 behavior.
  • Proficient in Trackwise.

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