Our client, a pharmaceutical company in Mayo are currently looking to recruit a Microbiology Laboratory Supervisor for their site.
The Microbiology Supervisor is responsible for the planning, supervision and control of a Microbiology project team involved in the routine microbiology laboratory activities including equipment calibration and validation, equipment administration, data integrity review of Laboratory systems, method validation and plant projects. All testing is performed in line with WWQA Standards and FDA, European and other MOH regulatory requirements.
The Microbiology Supervisor will ensure testing is completed appropriately & in accordance with procedures. The position holder will ensure a continued “on the floor” presence within the laboratory area and business unit cleanrooms actively engaging with, challenging and motivating team members and business unit personnel. The Microbiology Supervisor is accountable for the activities of Micro technicians within the team they manage. The Micro Supervisor must show the competence the overall management skills to ensure that the Micro function adds to the greater benefit of the facility from a Microbial control perspective.
In association with the Aseptic & Microbiology Manager the Micro Supervisor will work to meet company goals and objectives, customer requirements and the regulatory obligations as laid down by the FDA, EU and regional MOH.
- Provide guidance to direct reports to ensure activities are completed as per schedule and in a GMP compliant manner and in line with regulatory (QA and EHS) and corporate requirements.
- Maintain strong relationships with management and colleagues both within the site business units and the quality function, direct reports and customers. Articulate the necessary aseptic and micro requirements in a clear, concise and persuasive manner.
- Provide motivation to the team and take appropriate corrective action on individual/team performance where required.
- Hold performance meetings according to company policy.
- Update TMS and take appropriate action where an individual’s attendance / timekeeping is below the expected standard.
- Actively participate in the training and certification of new employees.
- Ensure that all aspects of the area of responsibility are fully staffed and that any constraints are managed appropriately.
- Coach and develop team members to support the Company’s succession planning
Communication and Data Management
- Ensure testing and monitoring is performed as per determined schedules and in line with regulatory requirements
- Ensure effective recording, analysis and reporting of Micro KPIs ensuring issues impacting quality performance are addressed and drive continuous improvement.
- Attend Departmental and OPEX meetings; Safety Gemba, Green Team Meetings
- Hold the agreed number of Team Meetings and Andon Board meetings.
- Attend other meeting as directed by the area Manager.
- Provide review and approval of local and corporate documents.
- Work directly with other Micro Supervisor to ensure that all testing is completed as per schedule.
- Ensure appropriate investigation is performed on out of limit results from testing.
- Ensure timely review of data generated within the team in conjunction with team reviewers.
- Work in conjunction with the laboratory trainer to ensure that sufficient technicians are proficient in the necessary tasks.
- Demonstrate active support and involvement in successful progress of compliance initiatives to enhance the site aseptic quality program.
- Represent the company in Ministries of Health inspections as deemed necessary as a subject matter expert in the field of Microbiology.
- Foster an environment of continuous improvements for the QC area by identifying and implementing efficiencies and quality improvements.
- Lead all new product introductions from a microbiology perspective, including but now limited to method validation, validation of cleanrooms, laboratory equipment validations, maintenance and calibration of business unit cleanroom monitoring system.
- Manage, oversee and validation activities associated with the aseptic manufacturing process via media runs.
- Proven track record in direct people management
- Scientific qualification in relevant discipline
- 4 years GMP experience
- Extensive knowledge of microbiology tasks and associated regulatory standards and guidance.
- Ability to anticipate, understand and address the changing regulatory environment of the Pharma/Medical Device industry.
- Assess implications of new regulatory guidance and implement necessary changes as they relate to Micro and aseptic.
- Ability to articulate clearly when dealing with external bodies
- Excellent conflict handling skills
- Ability to use sound judgment to make effective decisions within appropriate timeframes
- Proven to be self-directed, self-motivated and ability to prioritise competing priorities
For further information on this Microbiology Laboratory Supervisor role in Mayo please contact Clara Burke on 086-8168273 / firstname.lastname@example.org
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