Documentation and Compliance Specialist
Are you passionate about ensuring quality and compliance in the fast-paced world of life sciences? Join us as a Documentation and Compliance Specialist and play a pivotal role in managing and controlling crucial transfer documentation, supporting seamless technology transfer and New Product Introduction (NPI) initiatives. In this dynamic position, you will own the entire documentation suite, guarantee traceability and control, and act as the key liaison for audit and inspection readiness - all while contributing to innovative projects that shape the future of life sciences manufacturing.
Key Responsibilities:
- Own the Technology Transfer/NPI document suite, including transfer plans, protocols, and reports, ensuring compliance with controlled templates and numbering conventions.
- Coordinate change control, document approval routing, and maintain traceability back to source documentation.
- Support transfer readiness reviews ahead of each phase-gate, ensuring documentation is accurate and complete.
- Maintain transfer trackers and dashboards to support programme reporting.
- Act as the primary contact for internal audits and inspections related to transfer documentation.
Required Skills:
- Experience (typically 3+ years) in GMP documentation control, quality systems, or technical writing within a pharmaceutical or life sciences environment.
- Strong technical writing skills with meticulous attention to detail.
- Proficiency working with Quality Management Systems (QMS), document management, and change-control processes.
- Excellent coordination and communication skills, with the ability to manage multiple stakeholders.
- Ability to support compliance frameworks and audit preparation effectively.
Preferred Education and Experience:
- A background in pharmaceutical or life sciences documentation control, quality systems, or technical writing.
- Experience supporting technology transfer, NPI, or validation programmes.
- Familiarity with EU GMP Annex 1 (2022) standards for sterile manufacturing.
- Proven track record building or adapting document suites for new functions or programmes.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity, you will need to hold a Stamp 1G or Stamp 4 visa to apply. Apply via this advert or contact Siobhan Cummins on 021 4777329 if you have any questions about this role. Find out more about working with LSC at lscconnect.com
