Metrology Manager - Eurofins BioPharma Product Testing Toronto, Inc
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- Toronto, ON
- Permanent
- Full-time
- Supervise and organize the work of calibration group and setting timelines and work schedule
- Trouble shoot any equipment prior to coordinating its repair with the external vendors
- Perform annual performance reviews for direct reporting personnel
- Maintain instrument budget for all laboratories
- Perform data integrity analysis of software for the existing and new laboratory equipment
- Work closely with QA Director/QA Designate on creating, updating and reviewing site QA controlled documents related to calibration/qualification/maintenance activities
- Leading and initiating the Change Management process for any new equipment and lead the commissioning process.
- Establish and maintain professional business relationships with clients, industry officials and peers.
- Prepare, write and execute qualification (IQ/OQ/PQ) protocols for instrumentation
- Maintain the VMP and equipment lists with performing the annual review for the VMP
- Play an active role in internal and external audits and prepare audit responses
- Train employees on laboratory equipment and techniques and prepare training records
- Conduct temperature/humidity excursion investigations and prepare deviation reports
- Respond to the monitoring system alarms events
- Follow safety procedures within the labs and follow company policies
- Troubleshoot and respond quickly when problems arise
- Any other duties as requested by QA Director
- Bachelor's Degree in Science/Engineering
- 5+ years experience being a metrology manager/ head
- 10+ experience working in a GMP environment
- Solid experience in pharmaceutical testing operations
- Strong knowledge with cGMP testing & ICH guidelines and release procedures.
- Must speak and write English fluently
- Must possess excellent communication skills, both written and verbal, in order to maintain communication with internal and external clients
- Excellent organizational & inter-personal skills
- Ability to work independently, while supporting a collaborative, team-based department
- Must be proactive, self-disciplined, and able to demonstrate a high level of productivity with a goal-oriented approach
- Ability to effectively work under pressure.
- Exceptional technical skill related to laboratory instrumentation
- Ability to adapt to new technologies and software.