Overview
Quality Control Team Lead. 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 consistently with regulatory expectation and cGMP.
* Responsible for all aspects of guidance of a team of QC analysts/technicians, including performance management and the execution of business processes to a high standard as monitored.
* Support your team and help them to perform to a high standard, in the achievement of the company and department goals.
* Inspire enthusiasm and stimulate interest and guiding staff to ensure they are productive.
* Safety, cGMP, and Continuous Improvement.
* Ensure that Production, QA, Planning, Shipping and support departments receive an quality service through meeting scheduled target release dates and compliance standards.
* Training, recruitment, discipline and performing appraisals of QC analysts/technicians.
* To perform an investigation 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 in 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.
* To highlight and implement new technologies in QC area.
* To maintain the validated status of the LIMS/Empower systems and other relevant systems and to manage them to assure compliance with acceptable regulations and company policies.
* Support of Annual Product Reviews
* To act as designee for Manager; QC Laboratory in their absence.
General Responsibilities
* Participate fully in any cross functional training initiatives.
* Drive and promote the corporate values of Takeda-ism within the workplace.
* Actively foster, in cooperation with other TIL staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business. Ensure that Accident Reports / Near Miss Forms are completed in a timely manner after an event.
* Ensure timely completion of all SOP, reading, training and assessment.
* Other duties as required and directed by the Manager, Compliance or other Officer appointed by the Board of Directors.
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 analyst.
#J-18808-Ljbffr