Validation Specialist – Cell and Gene Therapy
Galway, Ireland | Permanent full-time role & flexible working conditions
HiTech Health focuses on enabling healthcare companies to develop, launch and supply products to the market. The company was established in 2013 in Dublin, Ireland, bringing together an experienced and multi-disciplinary team from across the pharmaceutical, biotechnology and medical device industries. Operating internationally, HiTech Health supports healthcare companies globally from the development to the launch and supply of products.
This is an exciting role for a highly motivated individual to join a growing organisation and be deeply involved in leading validation activities, to work as a Validation Specialist for our expanding laboratories in Galway.The candidate will work closely with clients and other functional units within Hitech Health including production to support the development and manufacture of a range of cell and gene therapy products, as well playing a key role in the growth of HiTech Health.
- Responsible for leading and executing Qualification and validation activities in a cGMP environment for key site processes, equipment and utilities and on-going process validation, in line with current regulatory requirements, corporate policies and site procedures (as per Validation Master Plans), including the generation/review of validation documentation (schedules/Risk Assessments/Protocols /Reports/Annual Reports/).
- Presenting executed qualifications during internal and external audits.
- Ensuring that a continuous state of validation is maintained for site equipment, systems and utilities, including providing validation input for site Change Controls.
- Responsible for executing site periodic reviews and revalidation activities.
- Accountable for writing, executing & reporting of all validation activities including but not limited to (FAT / IQ / OQ / PQ / FMEA Risk Assessments).
- Participate in project teams and assist in determining project schedules and the appropriate levels of validation.
- Support the development of the quality plans for ensuring all regulatory requirements are met during the validation of equipment, facilities, utilities, or systems.
- Ensure technical input and guidance on deviation investigations during qualification/validation activities in case of relevance or impact.
- Provide support to the local organization as validation SME and as a primary Point-of-Contact for the relevant Regulatory Agencies on occasion of Regulatory Inspections, Customer audits and for the relevant follow-up.
- Write and/or review and approval of functional area documentation (SOPs, Work Instructions, technical reports and protocols).
- Lead and/or participate in quality risk assessments.
- Assist in the investigation and closure of deviations and Out of Specification investigations.
- Ensure non-conformances/deviations are investigated and assessed for root cause and identification and closure of effective CAPA’s.
- To participate in inspections by third parties, e.g. HPRA, FDA, customers, etc.,
- Minimum of a bachelor’s degree in science, Engineering, Technology or a related discipline.
- Relevant experience as a validation specialist in a cGMP environment (3+ years).
- Full understanding of cGMP requirements including Annex 11 and Annex 15.
- Effective technical writing skills.
- Experience of working in an aseptic manufacturing environment is desirable.
- Good problem solving and investigation skills.
- Ability to work under pressure and meet deadlines.
- Highly motivated self-starter and team worker.
- Good organisational, coordination and communication skills and demonstrates good attention to detail.
- Rights to work full time in Ireland.
Salary Range: Negotiable. Salary is commensurate with experience and qualifications for this key position.
Working hours: Working hours will be 9 AM-5.30 PM daily. The nature of the work may require flexibility in working times.
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