Quality Assurance Manager

Quality Assurance Manager

ProductLife Group

Haan, Germany

Description

As a result of an increase in workload we are now seeking a Quality Assurance Manager responsible for acting as the technical expert, an escalation point for complex and high impact issues and decisions.

Responsibilities

  • Management of audit and inspection findings;
  • Develop and maintain a quality management plan;
  • Review and revise client PSMFs in collaboration with the QPPVs, as required;
  • Provide case quality verification and oversight including corrective action plans for cases not meeting quality standards;
  • Provide strategic plans for quality issues;
  • Assist in any investigating within the company including but not limited to the handling of deviations, complaints internally and at client sites;
  • Support in GMPD/GDP.ISO audits;
  • Support line manager on corrective actions for deviations/internal/external audits and CAPA’s;
  • Identify safety process efficiency/effectiveness issues and provide solutions for improvement;
  • Coordinate with the PV Operations Manager and Post-Marketing PV Manager to develop a training program.

Education

  • Bachelor’s or higher graduate degree in a science related field, or equivalent experience.

Experience

  • Minimum of 2 years of experience in Quality Assurance;
  • Knowledge of quality assurance, audits under GPx (ISO is a plus) and implementation of KPIs to improve CAPA monitoring;
  • Knowledge in regulatory affairs/vigilances/life science domain and medical devices being a plus.

Skills

  • Ability to work, plan and lead projects in cross function team;
  • Flexibility in working on diverse projects;
  • Fluent in English and German for daily contact with internal and external partners, French is a plus.

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© EuroJobsites 2019

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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