A Day In The Life Of A Production Support Team Leader
The purpose of this role is to lead & contribute to a team who support the sterile manufacture of filling and packing sterile and biological products utilizing both Blow Fill Seal (BFS) & Pre Filled Syringe (PFS) technologies.
In order the achieve this, the Production Support Team Leader will be required to: Apply knowledge of the manufacture of Sterile Medicinal Products (Annex 1) and Manufacture of Biological active Substances and Medicinal Products for Humans (Annex 2) to investigate, problem solve and conclude manufacturing deviations within the QMS (Quality Management Systems). Complete all other aspects of the QMS, including Change Controls, CAPAs, Effectiveness Checks, Customer and Supplier Complaints in accordance with procedures and ICHQ10, whilst leading a team of Production Support Specialists in achieving these goals.
Key Responsibilities:
Lead the team to monitor, maintain and analyse ‘on-shift’ technical data to identify corrective actions and improvements to the manufacturing process through visible management systems.
Comply with company policies & procedures (Current Good Manufacturing Practice cGMP, and Health Safety & Environment HS&E). Ensure health and safety/housekeeping standards are maintained. No critical or major observations and a maximum of 3 minor observations during external audits.
Facilitate technical/process data and give guidance in the areas of fault diagnosis. Monitor work operations business unit trends and standards and support the achievement of the manufacturing/filling/packing plan.
Investigate cell process related deviations to ensure Cell process activities are compliant with cGMP, GEP, and HS&E Complete Incident Reports/ CAPA close out in a timely manner.
Who We Are Looking For
Do you have?
Proven Leadership within a highly regulated, packaging production environment preferably pharmaceutical, chemical or food environment.
Sterile Pharmaceutical manufacturing experience would be ideal.
Knowledge and experience in completing Deviation Investigations/Technical Assessments/Reports or problem-solving RCA (root cause analysis).
Ability to present the departmental activities and debate technical issues with confidence.
Experience in Managing Change and Continuous Improvement through people.
Knowledge of working with biological active substances APIs would be beneficial.
Are you?
A good communicator/motivator/team player, with high attention to detail.
Able to deliver high performance standards consistently.
Comfortable working cross functionally influencing peers in area of expertise.
If so – we would value hearing from you!
