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.
If you have 10 years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Perform as a knowledgeable subject matter expert (SME), and single point of contact on site and network projects and programs, to advance aseptic operations
- Leading and/or providing input to strategic initiatives that will improve and develop Manufacturing processes for the future including Contamination Control and Aseptic Process Simulations (APS)
- Contribute in a team environment to operational issues pertaining to processes as they arise and provide expertise and support to help resolve escalated technical issues as required
- Remain current on state-of-the-art for systems and processes and advise on the appropriate adoption and use of new techniques and technology.
- 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 (Personnel and Environmental Monitoring), 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 timelines
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Bachelor's degree in Microbiology or related discipline with 5 + years' experience in the pharmaceutical industry, preferably in aseptic manufacturing.
- Experience with regulatory compliance in cGMP manufacturing and in-depth knowledge of Eudralex Volume 4, Annex 1 Manufacture of Sterile Medicinal Products.
- Proven ability to work in a high paced matrix organization and effectively influence change and escalate issues professionally and in a timely manner
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 Murphy on 021 4777329 if you have anymore questions about this role!
