Work Cell Specialist, CMC
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| Job Type | Permanent |
| Area | Dublin, Ireland |
| Sector | ManagementOperations & Manufacturing |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | #1002023 |
| Job Views | 161 |
- Description
- We are seeking applications for our client, who is a leading biopharmaceutical company based in Dublin. In your new role you will provide information insight and data analysis, drive execution of transactional/tactical tasks to ensure manufacturing and hub success.
Why you should apply:
This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.
What you will be doing:
Support the Site Operations Manager in all aspects of the business to ensure on time delivery of all key products and projects, with key focus and ownership of Quality records including Deviation records, CAPA, CAPA EV, and Change Control records.
Active participation in Work Centre Team meetings with the contract site as well as internal site team, working collaboratively with the four pillars of Supply Chain, Quality, Operations and Process Development.
Manufacturing operations: Ensure accuracy and completion of data entries and/or tasks for budget development, monitoring, and reporting; inputs to contracts, confidentiality disclosure agreement(s), scope of work agreement(s), request for pricing/information, supply agreement(s) etc. Own NC Class II/III records, CAPA, CAPA EV, and more complex change control records.
Site performance monitoring: Report contract site performance metrics to site lead; identify improvement opportunities for site performance; daily duties will include coordination, issuance, and review of meeting minutes, conclusions from analysis of data and metrics, continuous improvement and standardisation of performance tools, oversight and reporting of procurement/payment of invoices, and active participation in meetings with the contract site as well as internal site team.
Project Management and Technology transfers: Follow-up and track activities in a department-wide project from conception to implementation and close-out. Manage timeline and highlight risks of transfer team activities; manage risk management activities as part of transfer; provide escalation to the right level.
What you need to apply:
Bachelor’s in Business Administration, Engineering or Science-related field
4 years in roles requiring knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles
Proven matrix management and influencing skills.
Manufacturing and cGMP knowledge / experience.
Great negotiation skills.
Operational Excellence proficiency
The ability to drive continuous improvement.
Financial/budgeting knowledge and business acumen.
Proficient project management skills.
Problem-solving and critical thinking.
Understanding of contractual requirements.
Technical writing and multi-level communication skills.
Leadership skills in collaborative/team environment.
Be a self-starter, and work under minimum supervision
Show initiative and take action
