Qualified Person (QP)
Galway, Ireland | Full-time, Permanent 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, bringing together an experienced and multi-disciplinary team from across the pharmaceutical, biotechnology and medical device industries. Operating internationally, HiTech Health supports companies to develop, manufacture and supply life-changing therapies to patients.
We are seeking to hire a Qualified Person to support our rapidly growing business. This is an exciting role for a highly motivated individual to join a growing organisation and to be deeply involved in driving Quality Assurance and compliance activities within the company. The successful candidate will have the opportunity to work with a variety of clients and industry leading technologies to support the treatment of patients, including those suffering from rare and orphan diseases.
- Fulfilling the role of the Qualified Person within the company and for clients in accordance with EU Directives 2001/83/EC.
- Certifying Medicinal Products for use in the EU and outside the EU (where relevant).
- Reviewing Batch Manufacturing Documents to ensure compliance with EU GMP and the Product Specification File/marketing authorization (or other where relevant) as defined in 2001/83/EC, 2001/82/EC, 2011/62/EU and EudraLex Volume 4, Annex 13 and 16.
- Participate in Continuous Professional Development (CPD) initiatives with a view to maintaining, developing and broadening knowledge and skills as they relate to the function of Qualified Person
- 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.
- Undertaking audits in the EU and third countries to ensure that Sponsor or MA Holder manufacturing sites are operating in general compliance with EU GMP.
- Providing advice and guidance to the company’s staff and customers regarding QP requirements within the EU.
- 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
- Undertaking departmental tasks and projects outside of the job holder’s direct area of responsibility, in line with departmental and senior management team objectives
- Third level Degree in Science or relevant discipline.
- Eligible to act as a Qualified Person (QP) for the certification of Marketed Products and Investigational Medicinal Products in accordance with EU directives 2001/83/EC and 2001/20/EC respectively.
- Minimum 5 years of experience in pharmaceutical industry in a Quality role, preferably with at least 1 year experience as a releasing QP.
- Excellent working knowledge of quality systems, FDA and EU regulations, cGMPs and ICH guidelines.
- GMP Auditing experience of suppliers in pharmaceutical industry.
- Collaborative team player with a positive attitude and the ability to think and act quickly to identify creative solutions to complex problems.
- Strong judgment and decision-making skills
- Experience in aseptic processing, sterile manufacturing and cell and gene therapy manufacturing is desirable
- Direct experience in participation in regulatory audits
- Direct experience in development and oversight of Quality Management Systems
- 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.
- Some travel is required to support this role e.g., GMP audits. Approximately 10% of time.
The role will preferably be based in Galway, however other locations will be considered.
TO APPLY PLEASE SEND YOUR CV TO firstname.lastname@example.org