Job Reference: JO-2012-65507_1608114135
As our new Micro Lab Lead, you will help deliver an effective testing service for manufactured products while adhering to plant specification and schedule. Leading a talented micro team, you will take ownership of the micro lab operations and provide technical leadership to functional areas and key stakeholder.
- Ensuring laboratory documentation and computerized systems compliance with data integrity policies and regulatory requirements
- Developing expertise on regulations and business processes required to maintain micro laboratory data integrity
- Maintaining, approving, and reviewing all documentation relevant to the Micro Laboratory as required - advising on specification changes where necessary
- Assuring all test equipment used to disposition material is maintained and calibrated correctly
- Delivering sampling, inspection, and testing requirements of the lab team per the agreed schedule
- Working closely with Warehouse/Planning/Manufacturing and Production Teams to achieve sampling and testing schedules/priorities.
- Actively participating with internal and external audits and follow up on audit findings.
- Assisting in the resolution of specific manufacturing quality problems as required.
- Delivering the timely execution and completion of all phases of raw materials, in-process testing and finished products.
- Working cross-functionally in the transfer of test methods for new products.
- Carrying out specific tasks and projects as delegated by site management including the supervision of any personnel assigned to assist in the completion of the task.
- Updating management of system failures to ensure corrective/preventive action can be taken where required.
- Proving leadership for the micro team including talent management, identifying, and delivering training/support, acting as the technical lead.
- Leading adherence to and supports all EHS & E standards, procedures and policies for the micro lab team.
- Degree qualification in Biology/Microbiology (Masters/qualification preferable)
- Minimum 3 years' in a similar role within the biopharmaceutical industry
- Good knowledge of QA/QC operations with detailed knowledge of specifications, test methods, lab testing equipment
- Proven ability to supervise or lead a team
- Experience in supporting regulatory inspections HPRA, FDA etc.
- Knowledge and experience of cleaning validation desirable
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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