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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