Manufacturing Quality Team Lead

Posted 13 July 2022
Salary Negotiable
LocationWaterford
Job type Permanent
DisciplineScience Careers
ReferenceBBBH534251

Job description


Job Title: Manufacturing Quality Team Lead
Location: Waterford
Summary:
The Manufacturing Quality Team Lead is a critical role within the manufacturing and production support Centre of Excellence (CoE) of the QA and Compliance department of Pinewood Healthcare. Manufacturing and production support is one of four CoEs in the QA and Compliance Department of the Quality function; the others being: 1) Quality Systems, 2) Manufacturing & Production Support, and 3) Operations Quality. The Manufacturing Quality Team Lead is responsible for ensuring that all systems managed and co-ordinated by the function are maintained and compliant. The role holder will have strong attention to detail. The position works directly with site manufacturing, assuring compliance to the Quality Manager System.
Responsibilities:

  • Manage/ support and lead the team in ensuring smooth manufacturing operations, in handling deviations/ CAPA, change control, complaints, customer management, critical issues, recalls, etc. and that they are in full cGMP compliance to regulatory.
  • Provide oversight (Review/ Approval) of GMP Record/ Document in ensuring compliance
  • Ensuring manufacturing documentation is kept up to date
  • Review of cGMP documents to ensure company processes comply
  • Train and provide assistance to less experienced members of the QA team on quality procedures, protocols, and documentation
  • Maintain Quality Assurance documentation
  • Support investigation of quality issues with customers and suppliers
  • Review, approve and communicate root cause and corrective action to stakeholders
  • Corrective and Preventive Actions (CPAs) - Record and monitor all problems arising, with the objective of identifying the root cause and resolution
  • Ensure effective QMS and QA support is provided to operational functions to maintain batch release as per EU GMP requirement
  • Support Trackwise management of audits and inspections - including timely system entry, monitoring and follow up
  • Ensure own KPI's, plans, targets and objectives are optimally supervised and achieved


Requirements:

  • Degree in Science
  • Compliance to all policies, procedures, ethical standards and processes
  • Ensure close liaison with all departments and external suppliers to resolve and queries
  • Ability to oversee multiple projects simultaneously
  • Experience managing diverse relationships
  • Excellent technical writing skills
  • Exceptional ability to leverage/ collaborate effectively with internal and external stakeholders

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