Team LeadOperations Quality COE

Team Lead – Operations Quality COE
Newly created role on a growing pharmaceutical company based in Co Waterford. Reporting to the Head of QA & Compliance, The purpose of this role is:-
The Operations Quality Team Lead is a key role within the Operations Quality Centre of Excellence (CoE) of the QA and Compliance department. Operations Quality is one of three (3) CoEs in the QA and Compliance department of the Quality function, the others being: (1) Quality Systems and (2) Vendor Management. The Operations 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 a strong attention to detail. The position works directly with site manufacturing, assuring compliance to the Quality Management System
Responsibilities Include:
  • Manage/support and lead the team in ensuring smooth manufacturing operations, in handling deviations/CAPAs, 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 maintained up to date.
  • Review of cGMP documents to ensure company processes comply.
  • Train and assist 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.
  • Oversee the assessment and maintenance of quality related reports.
  • Provide training sessions in policies, processes and procedure as required.
  • Manage QA team members including assignment and supervision of work activities, setting of short-term objectives and monitoring performance.
  • Maintain the quality management system and site in a state of inspection readiness for regulatory inspections.
  • Ensure effective QMS and QA support is provided to operational functions to maintain batch release as per EU GMP requirement.
  • Compile and analyse data, writing reports, reviewing change requests and executed documentation on compliance related activities.
  • 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
  • Implementation of continuous improvement of GMP processes.
  • Support projects within the department and cross-functional on the site and/or within the network.
SKILLS, QUALIFICATIONS AND EXPERIENCE
  • Bachelor/Master degree in Science
  • Team Player
  • Compliance to all policies, procedures, ethical standards and processes
  • Ensure close liaison with all departments and external suppliers to resolve any queries
  • Ability to oversee multiple projects simultaneously
  • Experience in managing diverse relationships.
  • Excellent technical writing skills
Personal Attributes:
  • Outstanding organisational and time-management skills.
  • Exceptional ability to leverage/collaborate effectively with internal and external stakeholders