As Sterile Manufacturing Team Lead you will ensure the successful start-up of our new facility at Cambridge Pharma Limited by following all regulatory and company requirements. You will manage all operational activity related to the production of pharmaceutical products. You will ensure that product is delivered on time, in full and at the right quality and specification. As Team Lead you will also provide leadership, direction and coaching to all operational staff and set/manage objectives and KPIs for the Operations department team.
What you will be doing?
- Managing workloads, liaising with other departments on all matters relating to producing and supplying the product.
- Performing operational planning and communicating plans and performance across the site.
- Ensuring compliance with all regulatory requirements while maintaining excellent GMP and quality control.
- Acting as point of contact for manufacturing, providing GMP insight and input for new processes and equipment within CPL.
- Writing and reviewing new SOPs and Batch records and rolling these out
- Working in all areas of production, sterile operation, validation equipment, cleaning of a sterile facility.
- Ensuring good sterile and aseptic techniques are always followed.
- Correlating and presenting key KPIs and performance
- Responsible for Health & Safety and wellbeing of self, staff and visitors
- Assisting the Manufacturing Manager in running day to day operations
- Managing and developing the Manufacturing team
What we are looking for:
- At least 5 years experience in a GMP production role.
- Experience of sterile production and exposure to warehouse activity.
- Aseptic and sterile experience.
- Reviewer and approver of batch files.
- Preferably IOSH trained with a strong track record in health safely and the environment.
- Experienced in writing, reviewing Standard Operating Procedures for all aspects of Manufacturing with an understanding of warehouse or dispatching.
- Experience in overseeing validation of equipment from FATs to PQs.
- Knowledge of lean production or six Sigma and implementing continuous improvements.
- Strong organisational skills.
- Comfortable working within small, open teams on a variety of tasks
- Able to influence key stakeholders and build working relationships
- Open, honest, inclusive and personable
- A keen team player with strong interpersonal and communication skills
- Capable of leading and driving meetings to a decisive outcome
- Thorough, diligent, exercising a high level of accuracy
How do I apply?
If you are interested, please send a CV and covering letter to firstname.lastname@example.org with the subject line “Sterile Manufacturing Team Lead”.