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Basel, Basel-Stadt, Schweiz Gi Group SA Vollzeit{"title": "Quality Assurance Manager", "description": "Job DescriptionGi Group SA is seeking a highly skilled Quality Assurance Manager to join our team in Basel, Switzerland.The successful candidate will be responsible for supporting and driving the implementation of Annex 1 requirements at the Clinical Supply Centre for sterile Drug Product (Parenterals)...
Pharmacovigilance Quality Assurance Manager
vor 3 Monaten
The Role:
The Pharmacovigilance Quality Assurance Manager is a strategic role that drives enhanced compliance throughout the PV domain to support the obligation of the Marketing Authorization Holders and appointed QPPV, to maintain and improve a Global PV system in accordance with international regulations. He/She independently leads and manages the planning, conduct and reporting of PV compliance audit programs and ensures a standardized approach is implemented and maintained across all affiliate sites for PV and the related Quality System.
You Will:
- Act as a primary contact with internal stakeholders (affiliate, corporate functions), establishing and maintaining effective relationships, driving collaboration and providing expert-level PV knowledge and guidance on complex topics and issues.
- Act as local PV QA Manager appointed to affiliate sites and ensure implementation of a standardized PV system, consistent with HQ procedures. Support Idorsia affiliate sites as applicable in the establishment, implementation and management of their local PV system.
- Maintain, improve and assure execution of a risk-based, global PV QA audit program covering internal and external audits to verify adherence to the PV system, as defined in FDA and EMA Regulations.
- Perform PV QA audits of vendors across affiliate sites as applicable and of affiliates and maintain oversight of QA consultants appointed to perform PV audits on behalf of the company.
- Ensure audit results are formally and consistently tracked, recorded, reported, trended.
- Responsible for escalation of significant PV compliance issues to senior management.
- Provide in a timely manner the necessary QA output to the EU QPPV (and national ASMs, if applicable) to establish and maintain the PSMF Quality section and audit related PSMF annexes.
- Ensure inspection readiness of vendors conducting PV activities through metric review, vendor audit findings, CAPA generation and review, and training.
- Ensure procedures for archiving of records at affiliate sites are in line with Idorsia policies.
- Review the suitability of procedures for CAPA and deviation management, root cause analysis and perform QA effectiveness checks at HQ and at affiliate sites.
- Ensure appropriate and timely management of non-conformances related to relevant GxP: deviations, change controls, internal and external CAPAs, Quality Events.
Candidate's Requirements:
Strong background in Pharmacovigilance/Drug Safety and holds a master s degree in a relevant scientific discipline (Pharmacy or other scientific or health related fields), additional knowledge in Quality Assurance/Compliance and Auditing
- Expert knowledge of international Pharmacovigilance regulations (primarily, EU, US, Health Canada regulations & ICH guidelines) of medicinal products for human use.
- In-depth knowledge of pharmaceutical industry practices.
- Experienced in the training of employees on GVP requirements and pharmaceutical industry practices.
- At least 10 years of QA/industry/health authority experience, including theconduct of PV audits (e.g. at corporate HQ / affiliates; distributors; biopharmaceutical partners).
- Prior experience in the coordination of Pharmacovigilance inspections performed by Competent Regulatory Authorities, e.g. FDA, EMA, MHRA, ANSM, BfArM, Health Canada, Swissmedic.
- Languages: fluent in English - knowledge of German and French would be advantageous.
- Experience in GDP, warehousing and distribution of commercial products and commercial affiliate QA aspects to also act as Affiliate QA Manager/Supply Chain QA manager is an advantage.
- Proficient in the use of Microsoft Office applications.
Apply:
Please contract Rob Angrave on . Please quote 106497 in all communications. Applications must have the legal rights to work in Switzerland.
