LSC have a great contract opportunity for a Technical Support Analyst to join a global Biopharmaceutical company in Cork. The facility specializes in the fermentation, purification and sterile filling of biotech products, as well as supporting product development and clinical trials.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Support the process including trouble shooting and leading SPS for issues that occur on the shop floor.
- Managing EHS and Quality investigations and overseeing batch record reviews.
- Provide technical support to Operation functions and changes.
- Lead cross-functional problem-solving teams for troubleshooting and investigations within Vaccines IPT.
- Technical Report and investigation writing.
- Be responsible for the completion of continuous improvement projects to support manufacturing operations through the development of validation schedules, master plans and validation protocols.
- Be responsible for management and completion of Batch Record reviews
- Apply Lean Six Sigma and Lean methodologies.
- Represent the department on cross-functional project teams.
- Adherence to highest standards for Compliance (Quality and Safety).
- Ensure compliance with site EHS policy, cGMP and other business regulations and lead/co-ordinate Technical IPT input to risk assessments, audits, regulatory inspections and incident investigations.
- Ensure the highest Quality, Compliance and Safety standards by participating and complying with our Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- 1-3 years' experience as an operation role in a pharmaceutical or a highly regulated environment.
- B.Sc. Degree or other qualification in Biochemistry, Microbiology, Chemistry, Engineering or a related field.
- A working knowledge of the GxP systems associated with this role would be advantageous. These include, but are not limited to: GLIMS, eVAL, Delta V.
- Experience in Batch Record reviews.
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 if you have anymore questions about this opportunity!
