- The successful candidate will provide in-line technical support to ensure the continued manufacture and supply of quality pharmaceutical products in meeting the company priorities of: Compliance, Supply, Strategy and Profit Plan.
- You will be responsible for all aspects of method and equipment validation, assisting in the effective and efficient running of the method, equipment validation and small scale optimisation operations programs.
- You will also provide on-going technical support to the site in the area of contamination control.
Core Duties and Responsibilities:
- Promotes culture of EHS excellence in vaccines and provides high-quality safety leadership to assigned operations.
- Knowledgeable in protein chemistry and analytical techniques such as ELISA/Bioassay methods, Method validations, method transfers and Equipment qualifications in a GMP environment.
- Experience in Method Validation/ Method Transfers would be desirable.
- Participate in continuous improvement initiatives, including method optimisation and troubleshooting.
- Preparation of documentation associated with the projects in accordance with GDP (good documentation practice) and site procedures.
- Lead and Participate in cross-functional projects, problem solving teams for troubleshooting, and investigations across site.
- Prepare, review and approval of technical documents, procedures, CAPAs, change control, deviations, metrics, etc.
- Adhere to highest quality standards.
- The Analytical Sciences (AS) group require a Technical Specialist with strong analytical experience to provide multidisciplinary expertise and technical support to the Analytical Sciences team.
Minimum Qualifications and Experience:
- MSc/BSc. qualification (Science).
- At least 3 years’ industry experience working with ELISA/Bioassay in a QC/Analytical role group.
- High level written and verbal communications with advanced PC skills.
- Self-motivated and ability to work as part of a team with good project management skills.
- Demonstrated ability to fully realize improvement initiatives.
- Demonstrated successes in a team environment, such as project teams, problem solving teams etc.
- Stakeholder management of multiple decision makers, corporate colleagues, cross functional teams.
- Desired Qualifications/Experience: Minitab, Softmax Pro, JMP, Trackwise.
- Project management qualification is desirable such as, Project Management Professional (PMP).
- Evidence of Continuous Professional Development.
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
GC North Valley Business Centre, Old Mallow Road, Cork, T23 KC67, Ireland.
+353 21 2066178
Please note, we do not require agency assistance with this role.