Tgr cmf Team Leader
5 months ago
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Accountable for Overall Area Performance
- Ensure KPI targets are linked to and reported against the daily/weekly schedule.
- Ensure any negative performance variances to target have been reviewed, actioned or escalated if necessary.
- Ensure hourly/daily Gemba-walks/room support visits take place and are target-focussed.
- Drive team to successful batch close & clean up. Ensuring batch documented completed RFT and in a timely manner.
- Develop local ‘Room Action Plans’ to address shortfalls, or recovery plan to address why not achieving.
- Facilitate meetings for problem solving and feedback to the Production Manager.
- Develop & communicate area, team and individual objectives, goals & milestones.
- Set target-driven room/team expectations at shift start.
- Review Target v Actual with team at regular intervals throughout the shifts.
- Review final output and thank team for their efforts at shift end.
- Develop specific room ‘mini-goals’ with team and review daily/weekly and drive to completion.
- Attend micro-meeting room reviews of previous 24hrs performance.
- Develop and drive completion of short-term CI action plans for all activities in your department.
- Ensure downtime is captured and reported. On identifying any trends, work with engineering to address.
- Ensure room KPI board is updated on a SIC basis.
- Hold a.m. review of previous 24hrs performance and report to the Production Manager.
- Chair and effectively manage the shift/daily handover and mid-shift review meetings.
- Define and drive completion of short, medium and long-term action plans to maintain the equipment and rooms to acceptable levels of GMP.
- Ensure we are inspection ready at all times and maintain excellent level of housekeeping.
- Ensure room schedules maximise up-time and labour utilization.
- Use KPI performance data to coach/explain issues and formulate plans with room teams
- Ensure protocols are understood and followed if variance to manufacturing GMP procedure occurs.
- Use KPI performance data to coach/explain issues and formulate plans.
- Plan and drive execution update and maintenance of SOPs for the area.
- Ensure Area CI Action Log updated & maintained for short/med/long term.
- Develop Process Leads to ensure ‘ownership’ of role and individual development.
- Develop Area Capital Projects. Prepare/present Capex and implement if approved.
- Set specific area/individual objectives then drive to completion.
- Promote area teaching/learning culture and support (“What can I do to help?”)
- Constantly drive team to complete on line observations for CI.
- Promote best-practice holiday planning and disciplinary procedure.
- Proactively escalate any issue needing disciplinary action to the Production Manager.
- Ensure a safe working environment at all times and escalate issue to management where appropriate.
Join us and be part of building the bridge between life changing therapies and patients.
Let’s talk future
Equal Employment Opportunity (EEO) Statement:
- PCI Pharma Services is an Equal _Opportunity/Affirmative_ Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
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