Job Description
The QA Manager will be responsible for tracking, trending, reporting Key Quality Performance Metrics and providing continuous Improvement of the Quality Management System, to assure alignment with necessary Directives.
Reporting to the Operations Director
Responsibilities
Responsible for development, operation and management of integrated Quality Systems
Promote the development of a company-wide culture of quality assurance and implementing key elements related to the quality system
Maintain knowledge of existing and emerging regulations, standards, or guidance documents.
Ensure high-level quality throughout the entire supply chain
Partner with Operational activities with focus on both quality and on-time-delivery
Lead Quality complaint investigations, deviations, non-conformances, out of specifications, trending using quality system tools to identify root cause and ensure timely closure of identified Corrective and Preventative Actions.
Lead and continuously improve Site Quality Management System and assure compliance with applicable regulations.
Manage quality elements of solid oral dosage products from API through final packaging including management of CMOs.
Developing and implementing risk-based approaches to the batch review and disposition process.
Accountable for QP batch certification and release process.
Develop and maintain the Validation Master Plan and lead the site in meeting the plan.
Provide technical expertise during validations, qualification protocols, risk/impact assessments, traceability.
Coordinate validation projects for equipment, processes, facility, utilities, cleaning, and computer systems.
Required Skills
Bachelor's degree preferably in pharmaceutical sciences/ Chemistry with at least seven + years in Quality Assurance and/or Compliance.
5 + years of leadership and management experience in Quality functions.
Extensive knowledge of cGxPs, ICH and other pharmaceutical regulations.
For further information on this QA Manager position please contact Laurentina Kennedy at The RFT Group on 01 2302400 / Laurentina@rftgroup.ie. Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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