Quality Supervisor - Validation
My client, a multinational pharma company based in Dublin is looking to hire an experienced QA Supervisor. They ideally will have 3+ years’ experience in a similar role, have experience in Quality Assurance, Validation and must have strong people management experience.
This role is a 12-month fixed term contract.
- Provide Support and guidance for the Quality Validation Team.
- Work with Planning, Production, QA Production Support, QA Systems, QC, QP, and Materials Management to
- establish priorities; communicate issues and resolve issues; and communicate progress.
- Cross train QA Validation team on the various processes.
- Supervise key site quality systems such as Change Control, Deviations, CAPAs, Product Quality Reviews,
- Internal Auditing, Regulatory audits, Corporate audits, Site Quality Reviews, Document Management and Control, Technical Agreements and Site Master File.
- Measure, report and trends site performance on key indicators of these quality systems through metrics.
- Ensure quality system performance is appropriately and well communicated throughout site. Provide guidance
- and assessments to the site Quality Validation Team.
- Ensure site compliance with Irish Medicines Board, U.S. Food and Drug Administration and other regulatory authority regulations, as appropriate.
- Supervise and direct all deviation investigations.
- Develop a support/service mentality in Quality staff, partnering with local site departments.
- Support daily activities, ensuring QA personnel execute their work in strict accordance with SOPs, and cGMP guidelines.
- Seek process innovation and continuous process improvement in QA function.
- Establish the expectation and standards, and the supportive environment, to ensure that staff has the capability to meet performance expectations.
- Allocate and coordinate personnel resources to all QA compliance activities and provide direction to ensure that
- specified targets for team are met.
- Maintain accountability for own team’s performance metrics that support the annual operating plan and site strategic plan objectives.
- Ensure data reports on own team’s performance are current, accurate, and distributed according to defined procedures.
- Contribute to the continual improvement of QA documentation and ensure that they are current, accurate, and clearly define process and role responsibilities.
- Provide hands on training, support, and coaching to reports.
- Enforce cGMP, safety, housekeeping, and security procedures, maintaining a safe working environment and promptly reporting incidents and accidents to site leadership.
- Complete and conform to all training requirements for job role, including company-required and job role-specific training.
- Must have a relevant third level bachelor’s degree in Chemistry or related Science discipline
- Must have 3-5 years’ experience in a similar role working with pharmaceutical processing technologies with
- preferably some of this experience in Quality Assurance. Good understanding of 21CFR / cGMP documentation and electronic systems requirements.
- Must have strong people management experience in aligning individuals and teams to business objectives
- Must have exposure to Lean manufacturing concepts and experience in managing by metrics
What’s in it for you?
- Competitive package
- Life assurance
- Excellent company culture
- Excellent opportunity to develop experience and career in a multinational pharma company
For a confidential discussion and more information on the role, please contact Niamh Cregg