Charlottetown, Prince Edward Island
· Ensure that all planned activities are completed in line with HSE RA’s and unplanned activities are planned and executed as per risk assessments / permits to work.
· Supervision of high-risk activities such as Confined Space Entries.
· Drive and model behaviours in alignment with company principles with a particular emphasis on speaking up for safety and quality.
· Ensure tasks are completed by suitably trained operators and on the job training is tracked and completed.
· Own the area aseptic program and personnel qualification. Liaise with corporate expert as required to ensure that the area and team are maintained to the highest level.
· Ensure that production equipment remains in an appropriate state of maintenance, calibration and validation. Liaise effectively with process team and maintenance to ensure compliance.
· Owns team maintenance program, ensure completion on time in full.
· Own area cleanliness and feedback to contractor / maintenance any concerns.
· Raise deviations within 24 hours with quality information to ensure timely assessment.
· Work with process team on significant deviations to ensure that they are accurate and completed within 30 days. Attends the process team daily deviation meeting.
· Owns the team backlog (HSE and Quality). Drives completion to due date and ensures that over dues are kept to a minimum.
· Drive team performance by owning the daily shift huddle.
· Adapt huddle to respond to new issues to ensure resolution and solutions are sustained.
· Ensures the area housekeeping is maintained to a high level.
· Own area log completion and ensure always up to date.
· Ensure batch documentation is completed accurately and timely, according to the outline of production.
· Own SAP postings and inventory lineside to drive high accuracy all the time.
· Work with supply chain team to develop robust operational schedule to ensure that commercial demands are met in a compliant manner. Attends weekly scheduling meeting.
· Manage resource plan from vacations and cross skilling to ensure required operational coverage.
· Communicate and escalate schedule conflicts and propose effective solutions.
· Identify areas for improvement to improve schedule adherence and own implementation of actions.
· Work closely with the process team to identify and prioritize improvement opportunities.
· Act as key user representative for major capital projects, ensure design requirements are clearly defined early in project lifecycle.
· Coach, mentor and performance manage the team as necessary to drive the team performance.
· Drive reward and recognition for the team.
Minimum Qualification: (Education, experience and/or training, required certifications):
Experience: minimum specific experience required to perform the position.
· Three to five years’ experience in GMP Cleanroom Production area.
· Three to five years’ supervisory experience.
Education: Preferred educational requirement to perform the position
· Undergraduate degree – Science or engineering preferred.
· Aseptic experience in Grade A, B and C cleanrooms.
· Technical understanding of HSE and GMP requirements.
· Experience in root cause analysis - 6M and 5 why techniques
· Technical writing of reports to a high standard
· English required
· Computer literacy
· Monday to Friday 8am-5pm
· Possible overtime required
· Number of associates: 6-12