Manager, PV Quality Assurance

Highly Competitive
  1. Permanent
  2. Good Pharmacovigilance Practice (GVP)
  3. United Kingdom
Maidenhead, England
Posting date: 03 Feb 2021
35446

A global Pharma is looking for an experience Quality Assurance Manager PV to support Quality oversight.

Job Responsibilities

  • Manager, PV QA supports all the GVP QA responsibilities as listed below. Different members of the team will have specific focus areas:
  • Execute on global core auditing processes for licensing partners, external vendors, internal audits, affiliates, and other applicable service providers in a post-marketing environment.
  • Support cross GxP QA activities requiring PV expertise, as requested.
  • Determine, evaluate, and investigate Quality Events. Determine adequacy of root cause analyses and CAPAs. Applies risk-based thinking in determining required actions.
  • Effectively communicate and escalate quality concerns and critical matters to management.
  • Provide QA Audit, CAPA and Supplier data for the PV System Master File (PSMF). Develop and maintain efficient processes to ensure comprehensive and accurate data.
  • Develop and maintain processes and tools to support quality audit execution and outcomes.
  • Support PV / post-marketing surveillance inspection readiness and inspection management activities.
  • Support Quality oversight activities for PV and PV related vendors. This includes vendor notification, qualification assessments, Quality Agreements, KQIs and audits.
  • Develop and report PV QA metrics and dashboards to support Quality oversight.

Skills and Requirements

  • Educated to university degree (preferably life sciences) or equivalent qualification or experience
  • Experience in the Pharmaceutical industry in a quality or compliance function, GxP auditing, pharmacovigilance, regulatory affairs, and/or clinical research.
  • Audit skills, and experience of conducting GVP audits is preferred.
  • Knowledge of and working experience with international GVP regulations, FDA PV requirements, Health Authority guidances and ICH.

To Apply

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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