Purpose
The QC Lead Analyst 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 team works a 2-cycle shift pattern.
Occasional travel may be required for training purposes.
Responsibilities
- 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 review
- Perform various analytical techniques including but not limited ELISA/HPLC/Compendial Assays 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 in Carlow.
What skills you will need:
In order to excel in this role, you will more than likely have:
- Bachelors Degree or higher preferred; ideally in Analytical Chemistry/ Biochemistry or a closely related discipline
- 4+ years of experience in a pharmaceutical laboratory
- A good working knowledge of HPLC systems and software is desirable
- A good working knowledge of ELISA and Softmax Pro software is desirable
- A good knowledge of cGMP, GLP, Quality Management Systems