Do you want more variety and flexibility in your role? To work for a young and exciting Dublin based consultancy company? Then consider joining HiTech Health!
HiTech Health (HTH) focuses on enabling healthcare companies to launch and supply 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, HTH supports healthcare companies from the development to the launch and supply of products. HTH is authorised by the Health Product Regulatory Authority (HPRA) to perform batch certification of both commercial and investigational medicinal products.
This permanent position is an exciting role for a dynamic individual to join a growing organisation. The successful candidate will have the opportunity to work with a number of clients and to contribute to a variety of different projects.
The role of QP involves supporting the management of HTH’s Quality Management System to ensure it is efficient, effective and compliant at all times. The role also involves supporting Quality Assurance activities for HTH and for its clients. The QP will be responsible for ensuring compliance with U.S. and/or E.U. regulatory requirements for commercial manufacturing and release and for clinical supply to patients.
- Working closely with clients to ensure that products (drug substance and drug products) manufactured by contract organisations meet compliance with all relevant regulatory requirements and the client’s internal quality standards;
- Fulfilling the role of the Qualified Person within the company and for clients in accordance with EU Directives 2001/83/EC, updates and relevant current guidelines for commercially available product and/or clinical trial material;
- Performing batch documentation review and batch certification;
- Coordinating and performing any required internal/client investigations and the issuance of follow up reports (e.g. rejected batches, deviations, CAPAs, OOS);
- Ability to generate GxP 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 Quality & Compliance Lead on a regular basis to ensure client’s goals are being met in line with quality and compliance standards;
- Creating and delivering GMP training internally or externally on behalf of clients;
- Responsible for the day-to-day support of HTH QMS to ensure it is operating efficiently, effectively and in a compliant manner;
- Facilitating and/or supporting regulatory inspections;
- 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, Validation, 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 one of the following is desirable: solid/semi-solid dose manufacturing, aseptic processing, biologics manufacturing, cell and gene therapy manufacturing;
- 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 20-25% of time to support clients;