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CAREERS
| Microbiology Laboratory Manager |
| Date: January 13, 2012 |
| Reporting To:Director of Quality |
| Department:Microbiology |
| Location:Inverin, Co. Galway, Ireland |
ESSENTIAL DUTIES AND RESPONSIBILITIES:
To perform this job successfully, an individual must satisfactorily perform each essential duty. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.
- Manage and control the microbial testing of pharmaceutical products for release.
- Ensure highest quality standards are maintained in areas of responsibility and that industry best practice is adopted in accordance with current GLP, GMP and regulatory body directives.
- Ensure all laboratory analysis is carried out in a safe, efficient and timely manner and ensure that systems and methods of analysis, sampling and testing are in place to allow for the generation of valid data.
- Ensure validity of all test methods in the laboratory are established and documented.
- Interact efficiently with other department managers/ directors.
- Plan and budget for future resources in the Microbiology Laboratory so that efficiency of performance can be maintained in a continuous and predictable manner.
- Manage and support the Microbiology Team.
- Perform other duties as assigned.
QUALIFICATIONS
The qualifications listed below are representative of the minimum knowledge, skill, and/or ability required.
KNOWLEDGE
- Knowledge of working within an FDA/IMB regulated facility (preferably sterile injectables).
- Knowledge of Aseptic Processing.
- Knowledge of Monitoring and Management of the Microbial Environment.
SKILLS AND ABILITIES
- Ability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
- Track record of showing how results were delivered through management/leadership of others.
- Ability to provide leadership.
- Project management, resource planning and budgeting.
- Development and training of team members.
- Excellent communication skills (verbal and written).
- Ability to work cross functionally with other departments (Analytical, Quality, Manufacturing and Regulatory).
- Proficient computer skills (Excel, Word, PowerPoint, databases, Microsoft project planning (or similar software).
- Working knowledge of isolator technology.
- Working knowledge of Environmental Monitoring of a Pharmaceutical Manufacturing Environment.
SUPERVISION
Position functions semi-autonomously with support from Director of Quality. The position will involve direct management of 6 employees. Carry out managerial responsibilities in accordance with the organization's policies and applicable laws. Responsibilities may include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
EDUCATION/EXPERIENCE
Minimum of a Bachelor's degree in a science related discipline (preferably Microbiology/ Pharmaceutical Sciences) and 5 years managerial/supervisory pharmaceutical industrial experience preferably within a microbiology department.
However, a combination of experience and/or education will be taken into consideration.
LICENSES/CERTIFICATIONS
None
LANGUAGE SKILLS
Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence. Ability to work with groups of people such as other departments and communicate known concepts. Ability to present to a group of departments.
MATHEMATICAL SKILLS
College level mathematics ability required.
REASONING ABILITY
Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis. Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems.
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties.
Typically sitting at a desk or table. Intermittently sitting, standing, walking or stooping.
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties.
Laboratory Situation and Normal Office Situation.
TO APPLY
All applications should be forwarded to careers_bioniche@mylan.com
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