To work within the Quality Control Department for 12 months (maternity cover) to help maintain quality standards throughout the company.
The brief requires a thorough knowledge of Good Manufacturing Practice, current FDA & EMEA regulations for solid oral dosage pharmaceuticals for human use and a good working knowledge of manufacturing processes and packaging processes used in the pharmaceutical industry.
RESPONSIBILITIES: Ensure that the QC lab is in compliance with Good Laboratory Practice/Good Manufacturing Practice.
Implement and maintain standards of GLP practice consistent with regulatory expectation and cGMP.Responsible for all aspects of guidance of a team of QC analysts/technicians, including performance management.Safety, cGMP and Continuous Improvement.Ensure that Production, QA, Planning, Shipping and support departments receive a quality service through meeting scheduled target release dates and compliance standards.Training, recruitment, discipline and performing appraisals of QC analysts/technicians.Perform investigations into any non-conformance, instrument malfunction, accident or other abnormal occurrence.Validation, operation, maintenance, calibration and troubleshooting of laboratory instruments.Approval of relevant QC documentation.Support major projects, quality plans and continuous improvement programmes within the department and others.Prepare for and support external audits (HPRA, FDA, corporate, or client).Implement and maintain standards of safety to guarantee a safe working laboratory.
Ensure that the laboratory is kept clean, tidy and safe.Highlight and implement new technologies in the QC area.Maintain the validated status of the LIMS/Empower systems and other relevant systems and manage them to assure compliance with acceptable regulations and company policies.Support Annual Product Reviews.Act as designee for Manager; QC Laboratory in their absence.EDUCATIONAL REQUIREMENTS: BSc.
(minimum) in science or a related discipline.RELEVANT EXPERIENCE: 5 years experience in an analytical lab preferably with supervisory responsibilities.Technical experience of GC/HPLC Analysis required.Experience with continuous improvement plans within the QC environment.Experience managing, motivating and leading a team of analysts.
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