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Quality Assurance Team Lead
2 months ago
Job Summary:
SRG is seeking an experienced Quality Assurance professional to fill a new role as QA and Compliance Team Lead. 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: Ensure 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).
- Regulatory Compliance: Maintain site establishment registrations with regulatory agencies as applicable.
- Quality Management: Manage updates to Drug Master Files and issuance of regulatory compliance reports.
- Compliance Tracking: Coordinate tracking of site compliance commitments and follow up actions. Coordinate and support the delivery of Quality Compliance Metrics/KPIs to key stakeholders.
- GxP Trends: Identify GxP trends and communicate these to relevant stakeholders. Support compliance risk management activities and implementation of risk mitigation plans.
- Quality Improvement: Working with the wider site functions to drive down out of compliance events, identify and implement quality improvements.
- QMS Training: Coordinate QMS training for site employees and ensure this adheres to current regulatory requirements.
- Regulatory Findings: Support and track regulatory findings and trends that may lead into a focus of regulatory inspections.
- Single Point of Contact: Act as Single Point of Contact between site and Corporate Quality Team as delegated by QA Manager.
- Procedure Compliance: Assure compliance of procedures according to internal guidelines and UK/EU/US/ICH and other region specific guidance.
- Quality Management Review: Lead Quality Management Review meetings highlighting GxP areas of concern and working to support and track actions that are to be taken.
- Investigations and CAPA: Support quality related investigations, assist in the development and approval of effective CAPA in order to resolve product, audit and customer issues.
- Pre-Audit Preparation: Support effective pre-audit preparation, management and post audit follow up of customer audits and regulatory inspections.
- Quality Standards: 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:
- Education: Educated to degree level- ideally within a relevant scientific subject.
- Experience: Experience working within a GMP manufacturing environment.
- GMP Knowledge: Strong knowledge of GMP and pharmacopoeia guidelines.
- Audit Experience: Experience of performing self-inspections and audits of 3rd party suppliers.
- QMS Monitoring: Monitoring of QMS (including Deviation/Investigation/CAPA/Complaints).
- Audit and Vendor Assurance: Experience with implementation of audit and vendor assurance processes.
- Communication Skills: Strong communication skills.
- Workload Management: Ability to prioritise and delegate workloads to deliver on customer requirements.
