Description
Leading Healthcare Organisation are looking for a QC Manager to lead there QC team in there Biologics site in Cork.GENERAL SCOPE OF RESPONSIBILITIES:
- The timely and compliant qualification of QC Analytical Equipment and Systems, QC Analyst Method and Equipment Training.
- Approval of all required GMP documentation related to Analytical Method
- Timely completion of the Analytical Method Transfer process.
- Manages the QC departments to provide compliant, timely and cost effective QC Support to the plant.
- Manages the QC department's budget - human resources, overheads and capital expenditure.
- Defines Quality Control Policies, in consultation with QA and corporate guidelines.
- Identifies and implements efficiencies, cost reduction, quality and service level improvements.
- Proposes and agrees the functional goals for the area and provides timely routine reports to quality and plant management.
- Fosters a process-driven environment both within QC and with other Departments such that resources are employed efficiently and effectivel
- Promotes a continuous improvement culture and providing leadership in this area.
- Responsible for developing people and technical skills to implement new technologies and apply best practice.
- Represents CBIL where appropriate in meetings and other communications with regulatory authorities, industry meetings, etc.
- To ensure that all QC laboratories provide a compliant, timely and cost effective quality control service during the plant qualification phase and during routine plant operations.
ESSENTIAL:
- BS in a scientific/technical discipline required
- A minimum of 7 years' experience within the biological and/or pharmaceutical industry.
- 5 years of QC laboratory supervisory/management experience required.
- Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
- Demonstrated knowledge and application of industry regulations as they apply to QC
- Methods and procedures, including those of FDA, IMB, EMEA and other authorities.
An attractive salary and benefits package is on offer. If you are interested in this great opportunity please apply below with an up to date CV. Any questions or queries please contact me Anna Mooney .