Address
Form of work
SalaryContract: 11 month contract
Hours: Full-time, 5 days on site
Salary: To be discussed
Location: Co. Cork
A fantastic opportunity has arisen for an Operations Technical Specialist. The Operations Technical Specialist will provide process Technical Support to the Vaccines IPT team, and the role will be reporting to the Vaccines IPT Operations Manager.
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.
Skills & Knowledge:
- 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.
Contact: Louise Catherine Kelly | [email protected]
