Q.C. Specialist
ICDS Recruitment
Wicklow
Q.C. Specialist - Co. Wicklow. One year contract. You shall beresponsible for reviewing all QC related documentation, providing technical assistance to QC Analysts and Management as required; writing, approval and executing protocols and reports as required. The appointee will also be expected to carry out normal QC testing as needs arise. ESSENTIAL JOB FUNCTIONS: • Having all Analytical Test monographs in compliance with latest pharmacopoeia requirements and customer specific needs. • Participation in new product introductions and oversee any QC related tasks associated with same. • Specification, installation and validation of new equipment including PM and Calibration and training Analysts on same. • Liaising with third parties on equipment or test requirements. • Covering QC Analysts or Management as the need arises. • Writing, reviewing and as required executing protocols and reports. • Liaising with 3rd parties on analytical test issues. • Troubleshooting analytical issues. Assisting QC Technicians and Management with issues. • Oversee ordering of reagents and consumables within the QC department. • Responding quickly and positively to plant requirements. • Participating positively in team activities. • Maintaining complete and accurate records. • Effective and efficient use of laboratory equipment. • Reviewing all QC related documentation in time for shipping to the customer. • Final Approval of Raw Materials, Intermediates, Finished Products and Stability data. QUALIFICATIONS and EXPERIENCE SOUGHT: Essential: Degree –Science / Chemistry discipline or equivalent. Experience in a wide range of analytical techniques, particularly HPLC and GC. Desirable: Further professional education e.g. Masters. Essential: Circa 5 years’ minimum experience in a quality control role in an FDA/IMB regulated environment . Previous experience in data review and mentoring QC personnel. Skills/Knowledge sought: Critical: • Experience in a Quality Control role in the Pharma Industry with experience in HPLC/GC. • Excellent oral and written communication skills. • Attention to detail and good organisational skills. • Mature judgement, proven record of problem solving and decision-making ability. • Ability to operate in a team based environment. • Skilled in the use of computers. Essential: • Understanding of cGMP environment and regulations. • Experience in a wide range of analytical techniques. Desirable: • Chemstation experience. • Experience in electronic document management systems. • Stock control/purchasing experience. This job originally appeared on RecruitIreland.com.
2192 days ago