The continued growth in the development of cell and gene therapies (CGTs) has led to an exponential increase in the workload of the organisations involved. As ClinicalTrials.gov. indicates, there will be more than 1,000 ongoing clinical trials for CGTs registered in...
Qualified Person (QP)
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, 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 as defined in 2001/83/EC, 2001/82/EC, 2011/62/EU, 536/2014 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 project lead/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 clients 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 clients’ 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//536/2014 respectively.
- Minimum 3 years of experience in the pharmaceutical industry in a Quality role, with at least 5 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 or 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.
Salary Range: Negotiable. Salary is commensurate with experience and qualifications for this key position.
Working hours: Working hours will be 9-5.30 daily. The nature of the work may require flexibility in working times. Hitech Health provides flexible working options for employees.
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.
The role will preferably be based in the greater Dublin area, however other locations will be considered as remote work is possible. The QP will be expected to be present on site in HTH’s Dublin office when performing batch certification duties.
We reserve the right to re-advertise or extend the closing date for this job post.
HiTech Health is an equal opportunities employer.
The manufacturing of medicinal products for the EU market frequently occurs outside the EU zone and this presents logistics and regulatory considerations for the product owner. All stages of manufacturing medicinal products in third countries should be carried out in...
HiTech Health is delighted to be selected as the 'Spotlight' company by the Pharmaceutical Manufacturing Technology Center (PMTC). Read the article in the PMTC Monthly Spotlight. HiTech Health is a full-service Contract Development and Manufacturing...
Stay Up To Date
Connect with us to receive the latest HiTech Health and industry updates.