Quality 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 to work as a Quality 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.
As Quality Specialist, you will be responsible, with support from management, for providing general Quality support for key functional areas (i.e. Process Development (PD), Validation, Quality Control, Supply Chain, Quality Assurance, Information Systems), ensuring that programs, policies and procedures are robust and in keeping with regulatory expectations and local requirements.
This permanent position is an exciting role for a dynamic individual to join a growing organisation, focused on the Cell & Gene Therapy space.
The Quality Specialist reports to the Quality & Compliance Lead. The Quality Specialist will work across HiTech Health’s GMP and PD functions.
· Review and approve PD batch records against approved specifications, quality standards and company procedures for release of product on behalf of HTH clients.
· Review GMP batch records against approved specifications, quality standards, company procedures and regulatory filings prior to review and certification by HTH QP.
· 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 executed.
· Maintenance of HiTech Health Quality Systems including Training, Change Control, Deviations, CAPA, and Supplier qualification
· Assist in the investigation and closure of investigations, Deviations and Out of Specifications
· Ensure non-conformances/deviations/complaints are investigated and assessed for root cause and identification and closure of effective CAPA’s
· Perform QA review and approval of qualification lifecycle documents for facility & utilities, process equipment and laboratory instrumentation.
· Provide support for regulatory and customer inspection readiness, execution and follow up
· Participate in internal audit and program
· Lead HTH documentation management system and documentation control requirements
· Act in accordance with the company’s Guiding Principles and adherence to the company Code of Conduct.
· Compliance to all local site policies, procedures and Environmental, Health and Safety regulations.
· Perform additional duties as required.
Qualifications and Experience:
· Third level Degree in biology, chemistry, pharmacy or other relevant discipline
· 3-5 years’ experience in Pharmaceutical industry in a Quality role
· Sound awareness and understanding of pharmaceutical business, especially with regards to quality and GMP regulatory requirements
· Experience working with Quality Systems such as Deviations, Change Controls, Training, Supplier Qualification and Document Management systems required
· Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels
· High level of proficiency in English language (both spoken and written) required
· Ability to handle and prioritise multiple assignments, changing priorities and meet deadlines.
· Ability to work independently, as well as a member of a team in a dynamic, fast-paced environment
· Thorough, diligent, good attention to detail
· Results driven and creative with a can-do attitude
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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