Quality Validation and Quality Assurance Specialist – Cell and Gene Therapy
Galway, Ireland | Permanent full-time role | Salary commensurate with experience
HiTech Health focuses on enabling healthcare companies to develop, launch and supply products to the market. The company was established in 2013, bringing together an experienced and multi-disciplinary team from across the pharmaceutical, biotechnology and medical device industries. Operating internationally, HiTech Health supports cell and gene therapy companies develop, manufacture and supply life-changing therapies to patients.
We are seeking to hire a Quality Validation and Quality Assurance Specialist for our expanding laboratories in Galway. This is an exciting role for a highly motivated individual to join a growing organisation and be deeply involved in leading cGMP compliance and validation activities. 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.
- 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 particular relevance or impact
- Provide support to the local organization as validation SME and as a primary Point-of-Contact for the relevant Regulatory Agencies in 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 and provide quality oversight to ensure risk assessments are effectively maintained/ controlled.
- Assist in the investigation and closure of complaints, deviations and Out of Specification investigations
- Ensure non-conformances/deviations/complaints are investigated and assessed for root cause and identification and closure of effective CAPA’s
- Provide QA oversight and guidance on the evaluation and implementation of change controls
- To participate in inspections by third parties, e.g. HPRA, FDA, customers, etc.,
- Minimum of a Bachelors degree in Science, Engineering, Technology or a related discipline.
- Relevant experience as a QA validation engineer/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.
- Good professional standards, meticulous and demonstrates good attention to detail.
- Ability to work under pressure and meet deadlines.
- Highly motivated self-starter and team worker.
- Ability to work in a team-based environment and ability to manage a wide range of specific tasks.
- Good organisational, coordination and communication skills.
TO APPLY, PLEASE CLICK HERE: https://my.hrduo.com/candidate-jobs/Hitech_Health_and_De%C3%A1ntusaiocht_Slainte_Hitech_Teoranta/816437823
FOR MORE INFO: email@example.com
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