Excellent opportunity for a QC Manager to join a world renowned Cork based Company. The QC Manager is a key role in this start up environment, and the role is there for the ideal candidate to make it their own. Strong people management experience is a must for this one.
The position is responsible for compliance with material and product specifications, ensuring industry standard instrumentation and technical expertise for accurate analytical services in both chemistry and microbiology laboratories. Additional primary duties include compliance with GMP, GLP's and testing best practices, coordination with R&D, QA and Regulatory for specifications ensuring the identity, purity, strength, potency and composition of products.
The salary on offer for this role is €90,000 - €100,000, plus a benefits package including healthcare, pension, life insurance and bonus.
- Maintains knowledge of industry best practices in quality control systems and awareness of current technologies and instrumentation for all chemistry and microbiology analytical needs specific to production and quality assurance of all product lines.
- Oversees laboratory operations to ensure compliance with GMP, GLP's and internal quality standards through direction, authoring, reviewing and approving standard operating procedures (SOPs) for all Quality Control activities.
- Oversees current in-house chemistry and microbiology staff and workflow, laboratory qualification and requested testing based on approved methodologies and/or compendial requirements for fit for purpose quality control.
- Assesses laboratory technical skills and ensures continued training for personnel development.
- Coordinates with outside departments for integration of cross functional testing needs and/or improved standards for quality.
- Provides technical guidance and CAPA input in problem resolution where OOS instances occur in internal analytical processes.
- Completes regular reviews of trends in test results and use of resources; solicits participation from staff for setting of goals and improvement measures.
- Participates with QA for continual focus upon supplier base and vendor improvement through manufacturing communication and direct method discussion and transfer for all analytical needs.
- Reviews and approves all laboratory processes, validations, and reports in conjunction with approved QC SOPs.
- Provides and ensures use of effective tools for communication among staff and other groups relying upon QC services or support.
- Directly involved in training of outside departments on chemistry principals and analytical needs to intradepartmental collaboration for company objectives
- Oversees all manufactured product and stability testing needs.
- Ensures market or country specific testing requirements meet market regulatory needs to ensure product registration and confidence in analytical data.
- BS degree in analytical chemistry. Microbiology or related field required.
- At least 8 years work experience with a minimum of 5 years directly involved in the operation and management of analytical services in a GMP-regulated environment such as dietary Supplements or pharmaceuticals.
- In-depth understanding of all GMP-regulated quality unit responsibilities and analytical methods following the current federal regulation (CFR) guidelines.
- Ability to communicate a clear understanding of the Quality Management System to internal management.
- Ability to work with all Quality Management System interfaces to effectively implement and manage the system.
- Experienced level computer skills including word processors, spreadsheets, databases, quality management software, and statistical analysis applications.
- Advanced technical writing and problem solving skills
For more information on this role, please contact me, Julieann Fitzpatrick, at email@example.com and I will be happy to advise. Phone 021 2300 300.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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