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Quality Assurance Team Lead

2 months ago

Scotland, United Kingdom SRG Full time
Job Title: Quality Assurance Team Lead

SRG is seeking an experienced Quality Assurance Team Lead to join our team. As a key member of our organization, you will be responsible for ensuring compliance with regulatory requirements and industry standards.

Key Responsibilities:
  • 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.