Work with a large Environmental, Pharmaceutical and Medical device laboratory testing company who provide high class laboratory and customer data for their clients. Act as an experience figure to provide quality assurance and validation expertise and guidance for a Medtech/Biotech facility based in Galway.
Maintain and develop the onsite quality system, ensuring high quality standards are adhered to.
Represent the QC department in regulatory and client audits, ensuring timely resolutions of CAPAs, NCRs and Deviations or adverse findings through audits.
Ensure policies, procedures and validations are in accordance within cGMPs.
Author, reviewer and approver of SOPs, analytical validation protocols and reports.
Operate CAPA/deviation and customer complaints and identify and implement continuous Improvement programs as appropriate
Lead a team of QC Analysts, coordinating daily operations, revising SOPs and training staff.
Manage procurement of new equipment and coordinate the equipment qualifications. Execute IQ, OQ and PQ activities while reviewing qualification protocols and reports.
Perform internal and external audits and manage the overall auditing program.
Coordinate maintenance and calibration activities.
Maintain Quality Technical documentation and ensure clients are satisfied with performance of QA and QC function.
Validate Quality Procedures and Protocols.
Third level qualification in chemistry with five years or more experience e in quality management (QA or QC)
Must have Regulatory, QMS and Analytical experience.
To apply for this position please contact James Porter at Sigmar RecruitmentT: +353 91 455305E: firstname.lastname@example.org
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