Head of Quality
5 months ago
IQVIA are currently recruiting for a **Head of Quality and Qualified Person **to join a company that has a fantastic family feel and the backing of a successful large European pharma company. This is a hybrid role based in Slough.
This role is instrumental in managing the release activities for the company and leading batch assessments to ensure releases are carried out efficiently, in a timely manner and meeting relevant quality and regulatory standards. You will be managing Quality Assurance (QA) activities to ensure compliance with Life Cycle Management of the pharmaceutical products within the company GMP Quality Manual and all relevant EU regulatory and legislative requirements.
**The role**:
- Implement and manage the plan for the quality management system to ensure that management measures, activities and improvements are coordinated, allocated and are being performed to the necessary standards.
- Promoting compliance and adherence to Quality Policies, Standard Operating Procedures (SOPs) and training programmes
- Implementation of best practice to ensure GMP and GDP compliance across the company
- To perform internal and external audits (including manufacturer, packaging and suppliers sites) and supporting authority inspections as required
- Involvement with technical customer queries and product investigations as required
- Co-operation and communication with internal and external customers
- Planning and coordinating the implementation of any new legislative regulatory requirements in a timely fashion
- Honours level degree or higher in a relevant life sciences discipline (e.g., Chemistry, Biology or Pharmacy)
- Eligible as a Qualified Person (as described in articles 48-51, Directive 2001/83/EC, as amended)
- A current member (or higher) of the relevant professional body
- Relevant experience within a Pharmaceutical Industry (preferably generics) Quality Assurance/GMP background dealing with the requirements for finished product manufacturing, API, packaging, licensing, release and post-market responsibilities
- In-depth understanding and experience of GMP requirements, relevant EU Directives and Laws
- Excellent communication skills (both verbal and written)
This role is offering a very competitive salary and benefits package including 28 days holiday, private healthcare, wellbeing support and much more
LI-DNI
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