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Quality Team Lead

Ref: 77353

  • 45,000-50,000
  • 15 Jun 2022
  • Tipperary
  • Permanent

Quality Assurance Team Lead

About the Company

A leading Pharmaceutical Manufacturer in Tipperary requires an experienced Quality Assurance professional to lead a Quality Team on it's busy site.

About the Position

In this permanent, days role you will be responsible for QA and Compliance in the Manufacturing and Production areas.

Key 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.
  • 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, crafting 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.

Experience/Requirements

  • Bachelor/Master degree in Science
  • 3+ years of experience with some leadership experience
  • Ability to oversee multiple projects simultaneously
  • Experience in managing diverse relationships.
  • Excellent technical writing skills
  • Comfortable working in a busy, fast paced regulated manufacturing environment

Remuneration Package

Salary is negotiable depending on experience.
Contact
For more information on the role or any other Engineering or Life Sciences roles call Nigel on 087 3618142 or email me or click the apply button below.

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