Quality Assurance Specialist

GenevaFixe2018-06-08Non exigé / Non qualifié
Spring Life Sciences is looking for his client a

Quality Assurance Specialist

The Role:

• The Quality Assurance Specialist is in charge of the quality-related aspects of the products during distribution.
• This responsibility starts with the process validation phase, and lasts along the product life-cycle.
• The Quality Assurance Specialist is responsible to ensure that all the products' quality related matters are managed according to established procedures.
• The Quality Assurance Specialist works in close collaboration with internal and external resources and reports to the Head of Quality Assurance.

Responsibilities:

• Be involved in process validation
• Prepare and coordinate product launches
• Review and approve batch documentation records and related GMP documents,
• Ensure quality oversight of the day-to-day operations at contract manufacturers and distribution centers as per GMP and GDP guidelines,
• Follow all quality processes according to established procedures such as change controls, deviations, complaints, investigations, CAPA plan,
• Follow and review stability studies and Product Quality Review from contract manufacturers
• Participate to the qualification of suppliers and subcontractors, including performance of external audits
• Implement Quality Agreements.
• Support alert and batch recall process.
• Support the implementation and maintenance of the quality systems, including the
preparation of quality management reviews and audits (inspections and internal audits)

Profile:

• Pharmacist or equivalent scientific degree
• About 5 years of experience in Quality Assurance in a pharmaceutical industry
• Previous experience working in close collaboration with subcontractors
• Previous experience working in medical devices industry an asset
• Knowledge of applicable European and national regulations
• Knowledge of GDP/GMP regulations

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La référence de cette offre est JN -062018-49783 - HAID

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