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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 requirementsCarbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy