Salary: competitive & benefits & relocation package
Job Type: permanent
Closing Date: until position is filled
The job holder is required to work on their own initiative and largely independently on key responsibilities under the supervision of the Head of Contained Manufacturing Facility. The role is responsible for all aspects of their assigned process/equipment train, including client and auditor facing meetings. The role requires the individual to lead complex FD projects for assigned process, produce GMP documents, lead DR investigations and advise on CAPEX or CI improvements.
Qualifications, Skills and Experience:
- Degree educated or with at least 5 years’ experience within the pharmaceutical industry with excellent written and verbal communication skills.
- Working regulatory understanding for EU, US and Japanese markets including GAMP5 and 21 CFR11 compliance
Roles and Responsibilities:
- Lead technical transfer and scale up development of new projects coming from Formulation Development (FD) and client groups into the operations group.
- Able to act as SME for all internal and external needs
- Lead DR investigations
- Advise on CAPEX and/or CI improvements
- Liaise with all functions to ensure production schedules are adhered to 100% of the time and where this is not possible root causes are captured and actioned.
- To communicate effectively with internal and external customers and participate with them in problem solving and continuous improvement activities.
- Responsible for the reviewing of manufacturing batch records for technical transfer and continuous improvement projects in accordance with cGMP practices.
- Responsible for progressing and assisting in the technical aspects of process validation exercises.
- To assist in training of FD and Manufacturing personnel where required and promoting best practices for technical transfer and continuous improvement.