A new state of the art Quality Operations laboratory, and are looking for a QC Analyst who will report directly to a Lab Manager and who will help us lead the start-up of this laboratory . Initial tasks will be to help define procedures, processes, and 5S standards and contribute to the timely success of the start-up.
The ideal candidate will have 2- 3 years experience in a pharmaceutical laboratory, ideally with experience in HPLC systems and software. Core to the role is to perform testing of samples to support the release of our key drug products.
The candidate will contribute to the positive culture by providing an inclusive environment to enable team members to achieve their best work.
- 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 analytical team performing the allocated testing and laboratory based duties.
- Where applicable, review, approve and trend test results.
- Peer review other analysts documentation, ensuring QC Right First Time KPIs are achieved.
- Participate in QC daily meetings and ensure effective communication of testing progress, deviations etc.
- Ensure that all Quality Systems within the department are adhered to on a daily basis.
- Complete all documentation in compliance with GMP and GxP standards.
- Participate in the laboratory aspects of OOS investigations.
- Problem solving to get to root cause of issues.
- Provide support with audit/inspection requirements to ensure department compliance/readiness.
- Coaching and collaborating with others by sharing your skill-set and expertise.
- 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.
- Drive compliance with Merck Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions, including maintenance of accurate records.
- Bachelors Degree; ideally in chemistry, analytical chemistry or a related Science discipline
- 2-3 years of experience in a pharmaceutical laboratory.
- A good working knowledge of HPLC systems and software is desirable.
- A good knowledge of cGMP, GLP, Quality Management Systems