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Quality Assurance Team Leader
2 months ago
SRG are working with a leading life science organisation to help them find an experienced QA professional for a new role QA and Compliance Team Lead role.
This is a great opportunity for someone looking for a new QA challenge with great benefits and flexi-time on offer.
The Role:
- Compliance governance of key quality system elements, including scheduling and completion of; Quality Management Reviews, Qualification of Vendors, PQRs, Audits (Self-Inspections, Vendor Audits, Customer Audits).
- Maintain site establishment registrations with regulatory agencies as applicable.
- Manage updates to Drug Master Files and issuance of regulatory compliance reports
- Coordinate tracking of site compliance commitments and follow up actions. Coordinate and support the delivery of Quality Compliance Metrics/KPIs to key stakeholders.
- Identify GxP trends and communicate these to relevant stakeholders. Support compliance risk management activities and implementation of risk mitigation plans.
- Working with the wider site functions to drive down out of compliance events, identify and implement quality improvements
- Coordinate QMS training for site employees and ensure this adheres to current regulatory requirements
- Support and track regulatory findings and trends that may lead into a focus of regulatory inspections
- Act as Single Point of Contact between site and Corporate Quality Team as delegated by QA Manager
- Assure compliance of procedures according to internal guidelines and UK/EU/US/ICH and other region specific guidance.
- Lead Quality Management Review meetings highlighting GxP areas of concern and working to support and track actions that are to be taken.
- Support quality related investigations, assist in the development and approval of effective CAPA in order to resolve product, audit and customer issues.
- Support effective pre-audit preparation, management and post audit follow up of customer audits and regulatory inspections.
- Keep up to date and integrate current quality standards, guidelines and best practice on site. Ensure compliance by promoting understanding of the underlying concepts.
Requirements:
- Educated to degree level- ideally within a relevant scientific subject
- Experience working within a GMP manufacturing environment
- Strong knowledge of GMP and pharmacopoeia guidelines
- Experience of performing self-inspections and audits of 3rd party suppliers
- Monitoring of QMS (including Deviation/Investigation/CAPA/Complaints)
- Experience with implementation of audit and vendor assurance processes
- Strong communication skills
- Ability to prioritise and delegate workloads to deliver on customer requirements
Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.