PE Global is currently recruiting a SR QC Tech – Quality Operations Laboratoryon behalf of our client based in Carlow:
11-month initial contract- Shift (2 and 4 cycle available)
QC Analyst – Quality Operations Laboratory
The QC Analyst / Senior Technician Quality Control will report directly to the QC Manager and will help us in the expansion of this Laboratory and complete analytical method transfers and validation as well as commercial testing.
The lab operates a 2 cycle and 4 cycle shift and roles are available in both.
Occasional travel may be required for training purposes.
Bring energy, knowledge, innovation to carry out the following:
Work as directed by the Quality Control Manager according to Company safety policies, cGMP and cGLP.
Required to drive compliance with Global policies, procedures and guidelines and regulatory requirements and execute Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions
Participate in QC Tier 1 daily meetings and ensure effective communication of testing progress, deviations etc
Participate in writing/revising/ rolling out accurate operational procedures, training materials and maintenance procedures for various Quality systems; ensure all work is carried out in line with same
Operate as part of the QC team performing the allocated testing and laboratory-based duties
Perform various analytical techniques including but not limited to HPLC, (HIC, CE, IEX, HP-SEC), Capillary Electrophoresis and other compendial test methods in compliance with GMP requirements
Peer review testing documentation and ensuring data integrity compliance and QC Right First Time KPIs are achieved
Participate in the laboratory aspects of OOS investigations
Provide support with audit/inspection requirements to ensure department compliance/readiness.
Participate in internal and external audits and inspections, taking the role of auditee for assigned areas of responsibility.
Drive continuous improvement, perform root cause analysis on system failures and substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.g., FMEA, Fishbone diagrams, 5 why's etc,
Work collaboratively to drive a safe and compliant culture on site.
What skills you will need:
Bachelors Degree or higher preferred; ideally in Analytical Chemistry/ Biochemistry or a closely related discipline
The ideal candidate will have 2- 3 years' experience in a pharmaceutical laboratory, ideally with experience in HPLC and relevant systems and software.
Core to the role is to perform testing of samples to support the release of our key drug products.
A good working knowledge of HPLC systems and software is desirable
A good knowledge of cGMP, GLP, Quality Management Systems
Interested candidates should submit an updated CV.
Please click the link below to apply, call Audrey on ********** or alternatively send an up-to-date ******
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
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