Job Details:
Main duties and responsibilities
- Perform clinical Batch Release activities/Certificate of Analysis generation to target timelines as specified via Tactical Supply updates and JBIL QA.
- Assist in forecasting and schedule group and departmental activities.
- SME responsibility CRS Sample Management operations/LIMS.
- SME responsibility for batch release specifications and CoA requirements.
- Review and update clinical and manufacturing licenses. Review and update quality agreements with 3rd party test sites
- Co-ordinate sample management external outsourcing activities and manage external results/trending as the pr, where applicable.
- Ensure laboratory activities are carried out in compliance with cGMP and appropriate regulatory standards.
- Drive laboratory investigations in a comprehensive and timely manner.
- Actively improve CRS processes using Change Management/Change Control.
- Independently write/revise SOP’s or other official documentation and reports, when required.
- Act as mentor for new/existing personnel.
- Maintain and develop group training curriculum
- Execute independently and/or as part of a team, assigned projects/tasks.
- Keep up to date with existing and new SOP’s and official documentation.
- Take an active role in Lean & CI, identify and drive improvement initiatives.
- Participate in regulatory and internal audits as required.
- Represent CRS Cork where appropriate in meetings with leadership/customers/partners and other communications with regulatory authorities, industry meetings, etc.
- Act as Team Lead designee, as required.
- Perform other duties as designated by Laboratory Leadership.
Qualifications
Education and Experience/Competencies
- 3rd level qualification in a science related discipline.
- Knowledge of laboratory sample management and/or stability is essential.
- A minimum of 3 years’ experience within the pharmaceutical industry is preferred.
- Experience in Lean Tools/Project Management.
- Project management and problem solving skills.
- Problem solving and attention to detail.
- Coaching and mentoring style.
- Customer focus and result driven.
- Efficient, flexible and dynamic.
- Excellent communication skills.
- Strategic thinking.
- Work effectively with people that have diverse styles, talents and ideas...
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