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QUALITY MANAGER
Company:MORGAN MCKINLEY |
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Job Reference Number |
14566105 |
Client ID: |
RI/906000 / DS |
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Posted On: |
Feb 6 2012 |
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Location: |
SLIGO, SLIGO |
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Job Type: |
Permanent |
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Salary: |
NEGOTIABLE |
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Benefits: |
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- To manage the Quality Department (Quality Control and Quality Assurance) and in doing so ensure the manufacture of quality product in accordance with existing product licences and with GMP
- To provide direction and leadership for the site in meeting the sites commitments to all regulatory and quality standards
- To act as the final arbitrator on site for all aspects of GMP compliance
Key Responsibilities
- Manage the independence of the QA, QC and QP functions for the site ensuring they are appropriately staffed and adequately resourced
- Provide leadership and direction for the Site and ensure the site quality system is maintained in compliance with all relevant regulatory guidelines and corporate standards
- Ensure that any gaps in standards are captured on the site Quality Plan and have overall ownership for the plan
- With respect to Quality governance ensure the correct Quality oversight is in place and being used across the site to review and manage quality for all aspects of operations. (eg using DRB, Change Review Board, Self Inspection, QLT etc.)
- Develop and implement effective performance monitoring indicators for the quality function
- Manage, coach, and develop personnel within the quality function to ensure they have the product and process knowledge to enable them to perform scientific analysis of data to ensure potential risks to quality are identified and a state of control is maintained at all times
- Promote a strong site quality and cGMP compliance culture
- Promote and / or assist in the identification and implementation of appropriate product quality improvements, process improvements, variability reduction, in line with a culture
- Work with MS&T to ensure all processes are fully defined and controlled
- Direct and control projects within the quality function
- Work effectively as a member of the site leadership team, making key strategic decisions for the site
- Collaborate with other department leaders to resolve issues escalated to management
- Control spending and ensure budgetary compliance within the department
- Ensure adequate staffing and skills exist within the quality function and plan and co-ordinate quality resources to meet business needs on a daily, weekly and monthly basis
- Assist in identifying quality/ cGMP related training needs for site personnel and work with the training coordinator and area manager on developing comprehensive and relevant training programs
- In-line with overall Company goals and objectives, establish personnel goals and objectives, and scheduled / conduct employee performance reviews
- Complete duties in compliance with the Company's Environmental Health and Safety procedures
- Foster a good working relationship with all departments and uphold the Values of Integrity, Excellence and Respect for People
- Comply with the Company's HR Policies and Code of Business Conduct
Educational Details / Experience required
- Primary Hons. Degree or equivalent in Quality Management or another Science discipline
- Five (5) years experience in the FDA industry in a Senior Quality role
- Experience in FMEA and QRM
- Experience in IMB/FDA audit participation
- Excellent communication and presentation skills with a hands-on approach to team leadership
- Higher Degree (M.Sc./ Ph.D.) in a Science discipline while not essential would be an advantage
Skills in working to deadlines, planning, team leadership, motivating and developing subordinates - Excellent attention to detail
- Highly organised and an ability to work on own initiative.
