Job Description:

·         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.

Job Requirements:

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.

Additional Preferences:

·         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

Other Information:

·         Monday to Friday 8am-5pm

·         Possible overtime required

·         Number of associates: 6-12