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 supporting our businesses which stretch from quality and compliance services to our R&D and GMP facilities.
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 with an increasing focus on advanced medicines including cell and gene therapy products.
The Quality Specialist reports to the Quality & Compliance Lead. The Quality Specialist will work across HiTech Health’s services, GMP and PD functions.
- Ensure that the Quality System at Hitech Health is maintained and developed in accordance with the MIA requirements and in response to changes in regulations and legislation.
- Provide QA input into non-conformances/deviations/complaints investigations to ensure satisfactory root cause and identification and closure of effective CAPA’s.
- Lead and/or participate in quality risk assessments and provide quality oversight to ensure risk assessments are effectively executed.
- Perform QA review and approval of qualification lifecycle documents for facility & utilities, process equipment and laboratory instrumentation.
- Respond to customer complaints and undertake investigations accordingly.
- 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).
- Oversight and review of maintenance records (logbooks, cleaning records etc) of different functional areas.
- Review and update of all QA documentation as required in accordance with GMP.
- Provide support for regulatory and customer inspection readiness, execution and follow up.
- Participate in internal audit and program and ensure internal audit programme is adhered to, an audit reports are actioned in a timely manner.
- 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.
- Communicating with clients and providing Quality and Compliance advice and support in line with project timelines.
- Providing Clients with Quality and compliance support to ensure regulatory requirements are met.
- 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.
Employment Type: Full-time
Start date: On completion of recruitment process.
To Apply: Please apply via firstname.lastname@example.org and indicate the position title in the email subject line.
Applications to include a cover letter & CV. References should be made available upon request.
Location: Dublin or Galway. Potential for Hybrid working
We reserve the right to re-advertise or extend the closing date for this job post.
HiTech Health is an equal opportunities employer.
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