HiTech Health focuses on enabling healthcare companies to launch and support products. 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 from the development to the launch and supply of products.
This is an exciting role for a dynamic individual to join a growing organisation, to work with a number of clients and contribute to a variety of projects. The role involves leading Quality Assurance activities for HiTech Health as a service provider to clients. The candidate will play a key role in the development of the company. The ideal candidate will be primarily responsible for ensuring quality compliance with U.S. and E.U. requirements from early development right through to commercial manufacturing and supply to patients.
Key functions include:
- Working closely with clients to ensure that products (drug substance and drug products) manufactured by clients meet compliance with all relevant regulatory requirements and the client’s internal quality standards.
- Fulfil the role of the Qualified Person within the company in accordance with EU Directives 2001/83/EC, updates and relevant current guidelines for commercially available product.
- Coordinating and performing any required internal investigations and the issuance of follow up reports (e.g. rejected batches, deviations, CAPAs, OOS).
- Ability to generate documentation which is of a high standard. QA review of documentation, including SOPs, Protocols, Batch Records, Validation documents and Quality Technical Agreements (QTAs) to ensure GMP compliance.
- Acting as a point of primary contact for clients.
- Advising and providing input to clients’ quality management systems.
- Conducting GMP and GDP audits on behalf of clients and subsequent issuance of reports.
- Participating in cross-functional projects for the development and scale-up of products.
- Reporting directly to the Managing Director on a regular basis to ensure client’s goals are being met in line with quality and compliance standards.
- Third level Degree in Science or relevant discipline.
- QP Qualification is essential.
- Minimum 5 years of experience in Pharmaceutical industry in a Quality role. Possibly experience in finished product manufacturing, including QA, QP, QC and/or analytical chemistry.
- Excellent working knowledge of quality systems, FDA and EU regulations, cGMPs and ICH guidelines.
- Auditing experience of suppliers in pharmaceutical industry is desirable.
- Biotechnology compliance knowledge and experience.
- Experience in participation in regulatory audits is desirable.
- Experience in people management is favourable. Ability to critically assess situations and make strategic decisions.
- Excellent Time Management and Project Management abilities.
- Excellent written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally.
- 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.
- Travel expected 10-15% of time to support clients.