LSC have a great contract opportunity for a Manufacturing Specialist to join a South Dublin based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging.
Description
As a Process Owner Lead, you will be an established professional who is a self-starter, capable of applying advanced process knowledge and creativity to complete complex assignments related to the manufacturing operations. You are someone who contributes to the development of new principles and concepts, who wants to be challenged and can lead change from a manufacturing operations perspective.
Supporting key areas of the business, the Process Owner Lead will direct initiatives that improve the reliability and efficiency of manufacturing processes in addition to day-to-day support related to unplanned event troubleshooting, investigations, CAPA identification and implementation.
Primary responsibilities:
- Perform as a knowledgeable subject matter expert (SME), and single point of contact on site and network projects and programs, to advance manufacturing and aseptic operations through ownership of the assigned processes and taking a proactive approach to safety, quality, and compliance by actively seeking opportunities to remove error traps.
- Accountable for process documentation (e.g., SOPs, Training, Electronic Batch Records, Risk Assessments) in assigned area of responsibility. Gatekeeper (develop, review and update) of process documentation to maintain structure and control over generation and revision ensuring the documents clearly and correctly direct the process.
- Use subject matter expertise to identify and lead continuous improvement projects in assigned area of responsibility. Ensure project timelines are met, challenges identified, mitigations are in place and communication plans delivered to all stakeholders.
- Involved in the daily business management systems and reporting, have a clear understanding of what is happening in the assigned area of responsibility. Monitor any process trends including business performance metrics. Identify actions that will enable the process and the Manufacturing areas better achieve and surpass metrics in the future.
- Lead and/or Support investigations that impact on safety, quality and/or compliance of the processes, ensuring thorough investigations are conducted and actionable CAPAs, to prevent future reoccurrence, are implemented within agreed timeline.
- Ability to lead change from an aseptic operations perspective is a plus.
What you need to apply:
- Bachelor's degree in Science, Engineering or related discipline with 5 + years' experience in aseptic Drug Product Manufacturing or related cGxP manufacturing experience.
- Experience with regulatory compliance in cGMP manufacturing and in-depth knowledge of Eudralex Volume 4, Annex 1 Manufacture of Sterile Medicinal Products.
- Excellent Decision-Making skills and confidence to challenge others respectfully and professionally on decisions that impact the manufacturing area.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Adam @02147777329 if you have any more questions about this opportunity!
