Description:
Support the clinical trials packaging function at the Moreton site ensuring clinical trials material is produced to the highest of standard for the patient.
Part of the packaging and labelling supervisor team ensuring the patient kits are produced under cGMP, on time and right first time.
Key Responsibilities
- Demonstrates a thorough working knowledge of the clinical supply process and the technical aspects of the cGMP’s as they relate to product packaging and labeling.
- Exhibits sound judgment and strong supervisory skills by executing shop floor orders against required timelines while utilizing shop floor resources in an optimized efficient.
- Utilizing SAP, delivers complete, error free technical documentation supporting packaging & labeling production processes.
- Demonstrates knowledge with a range of production equipment and can troubleshoot and resolve problems as they arise.
- Establish and support a work environment of continuous improvements that supports the Company’s Quality policy, Quality Systems and the appropriate regulations for the area.
- Utilizes technical writing skills to generate DI / QRM assessments, Safety risk assessment, procedures and guidelines.
- Participates on teams representing global packaging organization as subject matter expert.
- Interacts and liaises with team members from Clinical Supply Operations, Quality, Clinical Supply Logistics and Analytical & Bioanalytical Development.
- Oversees and or conducts training of new or existing employees and ensures their training is documented.
- Leads root cause investigations for process deviations and assigns Corrective/Preventative Actions
Key Skills Required
- Prior Supervision of production staff or leadership role within a production operation with demonstrated ability in scheduling, organizing and team building is required.
- Knowledge of cGMP’s and regulatory (i.e. MHRA etc.) requirements and their application within a packaging and labeling production environment.
- Solid record of attention to detail and strict adherence to all procedures and regulations.
- Good understanding of the pharmaceutical development process and associated scientific principles,
- Excellent written and communication skills. Demonstrated ability to liaise with various support groups and lead in a team environment.
- Effectively manage competing priorities, adaptable to change, demonstrated ability to accept additional responsibilities and mange tasks thought teamwork.
- Knowledge of computers using MS Office, MS Outlook and business software systems commonly used in pharmaceutical industry (i.e. SAP, Infinity).
- Demonstrates the ability to effectively schedule multiple jobs / orders.
Education And Experience Required
- Bachelor of Science or a Mechanical Engineering Degree
- Demonstrated experience in a pharmaceutical industry preferably pharmaceutical manufacturing with a focus in the production of Clinical Trial Supplies.
- Extensive experience of progressive leadership or supervisory experience in the pharmaceutical industry