Compliance Specialist

  • Location

    Cork, Republic of Ireland

  • Sector:

    Life Science

  • Job type:

    Temporary

  • Salary:

    €50000 - €51000 per annum

  • Contact:

    Immaculada Diaz

  • Contact email:

    admin@live.dev

  • Job ref:

    BBBH2346_1590746624

  • Published:

    about 2 months ago

  • Expiry date:

    2020-06-28

Provide change control support for the manufacture and testing of clinical and commercial biologics, vaccines and small molecules Drug substance and Drug products (cross modality).
Reports to Associate Director QA Change Control.

Change Control activities include:
- Position will involve assessing, reviewing and progressing change control documentation from all areas on site as part of a cross-functional team.
- Act as a technical expert in area of responsibility for change control management and the change control process, and work with minimum supervision while ensuring communication to area leadership.
- When a change is proposed, in area of change control responsibility, participate in defining change control strategies and project timelines, while considering operational impact to the site.
- Review change control documentation for clarity, ensuring relevant supportive data has/ will be generated.
- Confirm categorisation of change in accordance with site and Global procedures
- Collaborate with site Change Owners, SMEs, and CMC to determine impact to Clinical / commercial licenses for proposed changes.
- Provide Change control support as required during HA inspections
- Provide change control training to the site in accordance with procedures
- Share best practice with the team and the network
- Carry out annual product reviews from Change Control Perspective
- Any other tasks as deemed necessary to support the change control function

Qualifications:
- Degree in biochemical/ biomechanical engineering or equivalent. Advanced degree preferred

Experience:
- Years operations experience -Regulatory / Technical / QA experience in a manufacturing operations environment and/or support function or equivalent.
- Equipment / validation / C&Q / software engineering experience desirable
- Project management skills