GCP QA Auditor
Servier
- Laval, QC
- Contract
- Full-time
- 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
- Knowledge of audit methodologies to be applied to R&D and Pharmacoviliance activities,
- Leadership skills,
- Strong capacities to work transversally,
- Be proactive.
- 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!
- Un régime d'assurance collective et de retraite attrayants
- Une rémunération concurrentielle incluant un bonus à la performance
- Un compte soins de santé
- Un programme d'aide aux employés
- Une prime sportive
- Des valeurs d'entreprise centrées sur l'épanouissement des collaborateurs ;
- Et bien plus encore!