Job Description
We are seeking a Quality Assurance Expert to join our QA team.
This key role provides quality subject matter expertise (SME) and oversight to enhance our quality management systems, supporting global pharma in the production of life-saving medicines and therapies.
You will be responsible for ensuring QMS processes are efficiently maintained and conform to internal and external client requirements.
You will engage cross-functionally with SME team members to enhance our QMS and support client processes.
* Collaborate with commercial and technical operations teams to deliver QA objectives and support business growth.
* Track and report metrics and key performance indicators for the Quality Management System.
* Collaborate with stakeholders to identify value-added improvements and key performance indicators.
* Review and follow up on open actions related to CAPA, OOS reports, and Deviations.
* Support Client quality audits and address findings and required actions.
* Manage the Internal Audit program, including coordinating audit schedules, reviewing findings, tracking corrective actions, and providing insights and initiatives for continuous improvement.
* Provide forward-thinking solutions and identify opportunities to add value to team deliverables.
* Assist in developing systems and processes to ensure information delivery across functions, supporting an enhanced performance culture.
* Document Control - Site lead for managing Meissner SOPs and Document Control.
* Manage quality training programs at Castlebar site to ensure effective mirror of HQ processes.
* Site lead for training compliance to Meissner SOPs.