GCP QA Auditor

3 months ago

Laval, Canada Servier Group Full time

Select how often (in days) to receive an alert:

Servier Canada is a wholly owned subsidiary of the Servier Research Group, a private French pharmaceutical firm active in over 140 countries around the world. Entirely independent, the Group reinvests 25% of its turnover in Research and Development and applies all profits towards development. The Group’s growth is driven by a constant search for innovation in 4 areas of excellence – oncology, cardiovascular, immuno-inflammatory and neuropsychiatric diseases.

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MAIN MISSIONS AND RESPONSABILITIES

Conduct and management of audits in GCP perimeter to ensure compliance with the company's quality policy, internal procedures and regulatory requirements.

  • Advise and support the audited structures in the design and implementation of corrective and preventive actions (CAPAs) to ensure compliance with regulatory requirements and internal procedures.
  • Approve corrective and preventive actions (CAPA) related to audits and follow up until the audit closure.
  • Analyse and monitor the key performance indicators of quality audits and share the analysis with the Quality Management System (QMS) team and any other relevant business.
  • Outsourcing management for audit activities (drafting of specifications, subcontractor selection, planning, of audit reports review and follow-up of activities such as report distribution, CAPA approval and audit closure).
  • Lead or participate in working groups for the drafting/updating of documents related to audit activities.
  • Advise, guide and support the concerned structures (subsidiaries, partners) in the overall management of regulatory inspections (GCP, GVP), including the preparation, follow-up and support on preparation of responses to the regulatory authoritie

SKILLS AND TRAINING REQUIRED

Expected skills : Expert on GCP and other international guidelines. Well organized, efficient, excellent interpersonal and team building skills. 

Education: Medical doctor, Pharmacist, Master of science and specific Quality Assurance training. 

Professional experience: At least 3 years’ experience in the conduct of GCP audits. Experience in the preparation/hosting of GCP inspection is a plus.

Specific skills: 

  • Knowledge of audit methodologies to be applied to R&D and Pharmacoviliance activities,
  • Strong capacities to work transversally,
  • Be proactive.

Languages: Fully fluent in English 

Travel : At least once per month 

Location: Europe and Canada

What We Are Offering:

  • An attractive group insurance and retirement plan
  • Competitive remuneration including a performance bonus
  • A health spending account
  • An employee assistance program
  • A sports allowance
  • Corporate values centered on employee development
  • And much more

Whatever your area of expertise, your work within the Servier Group helps advance therapeutic progress for the benefit of patients. You will be part of teams recognized for their scientific excellence and reach your full potential in a professional environment that encourages you to develop yourself. Tailor-made onboarding journeys, mobility opportunities, quality training, responsible management, team spirit......all this and more in a workplace focused on your well-being.

At Servier, we are committed to therapeutic progress to serve patient needs. We put the diversity of our employees as a source of richness for the fulfillment of this vocation.

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