QC Manager
QC Manager
Excellent opportunity for a QC Manager to join a thriving company in Limerick.
The QC Manager will serve as a subject matter expert in the QC Laboratory. The QC Manager will work with QC personnel to assure the completion of laboratory functions by providing direction to the QC Team. The QC Manager will ensure that daily laboratory testing of raw materials, in process and finished products are completed as required. In addition, the QC Manager will be responsible for providing leadership and direction for environmental testing, validation, stability and other various laboratory and production testing as needed.
Key Responsibilities:
- Responsible for all personnel in the QC Laboratory including training of all new employees and maintain all training documentation via current system
- Manage day to day shift prioritization of routine, in-process, stability and finished product work
- Facilitate QC audit readiness with understanding of FDA and ISO regulations and requirements
- Apply compliant laboratory techniques as per industry standards (e.g., FDA, USP/NF, ISO, ANSI) and internal & customer requirements.
- Directs implementation of the OOS system Laboratory Investigations, and assist in any related CAPAs, deviations, etc.
- Perform and provide oversight as applicable to advance chemical testing using analytical instrumentation including HPLC, GC, FTIR, UV-VIS, etc.
- Employ sound and compliant laboratory techniques and logic per industry standards (e.g., FDA, USP/NF, ISO, ANSI) and internal and customer requirements.
- Directs troubleshooting activities of analytical instrumentation and basic maintenance
- Design and implement performance improvement plans and targeted developmental training for all QC Laboratory personnel
- Provides metrics for site QC Laboratory functions
- Writing and revising SOPs and WIs to ensure cGMP compliance.
- Review batch records to ensure they are compliant with SOPs, WIs, and cGMPs.
Key Requirements:
- Degree or Masters in Chemistry or related scientific field
- Minimum 7 years relevant experience
- Subject matter expert in Analytical Sciences
- Excellent proficiency with HPLC, GC, KF, FTIR, and other wet chemistry methodology
- Experience working in an ISO or FDA regulated environment
- Expertise with Empower
- Expertise in transfer validation, test method transfer, test method validation
- Excellent communication & interpersonal skills
- Ability to problem solve and make decisions that are GMP compliant.
For further information please contact Loretta Flynn
[email protected]
086-1838380
INDPERM
