Qualified Person (QP)

Qualified Person (QP)

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.

 

Responsibilities:

  • 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

 

Requirements:

  • 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.

 

Location:

The role will preferably be based in Galway, however other locations will be considered.

TO APPLY PLEASE SEND YOUR CV TO recruitment@hrduo.com

 

EU Market Access for UK Companies

EU Market Access for UK Companies

EU Market Access for UK Companies

The UK life sciences industry contributes over £30 billion to the UK economy, and supports almost half a million UK jobs. The UK is a leading centre of medical research and biopharmaceutical innovation and is at the forefront of drug development and approval. With the Brexit transition period ending in less than six weeks, the UK pharmaceutical industry is increasingly focused on taking actions to ensure the continuity of supply of their products to patients during this transition, and to ensure their companies’ long-term access to markets and providing products to patients throughout Europe. This has been made all the made difficult by Covid-19 and its devastating impacts.

What we know so far is that, from 1st January 2021, the following will occur:

  • Marketing Authorisation (MA) holders, if held in UK, will have to be transferred to an EU or EEA country.
  • Each consignment of UK-manufactured Active Pharmaceutical Ingredients (APIs) to the EU/EEA needs to be accompanied by an MHRA certificate of conformation to EU GMPs.
  • Each batch of UK-manufactured drug product intended for the EU/EEA market will need to be released by a QP within the EU/EEA.
  • Pharmacovigilance of drug products placed on the EU/EEA market will need to be managed from a location within the EU/EEA.
  • There will no longer be unrestricted transport of goods between the EU and the UK.
  • Expect added paperwork, transport delays, and likely customs duties.

 

HiTech Health can act as an extension to your internal team within Europe. We offer Qualified Person (QP) services for the batch release and supply of medicinal products that can save you time and money when compared to building this expertise internally in Europe. With existing customers in the UK, we can provide a team to enable all the EU activities including product importation, QP certification and management of supply chain through to your distributor.

For the importation of medicinal products from the Great Britain (GB) to the EU, HiTech Health can act as the Importer of Record (IoR) for your company. Movement of goods from GB to the EU will be classified as international movements. Therefore, such movements will require transit declarations and tariffs. These tariffs will depend on the provision of a product identification code and HiTech Health can fully support you with this process.

The support we provide will be tailored to your company’s needs. Please email us at info@hitech-health.com to request further information on the range of services we can provide.

Recent News

HiTech-Health awarded with government funding

HiTech Health awarded with €7m government funding for 'disruptive' project   HiTech Health and our partners, Relevium Medical and Professor Garry Duffy’s Laboratory at NUI Galway are honoured to receive €7 million from the Disruptive Technologies Innovation Fund...

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HiTech Health Launch New Website

HiTech Health Launch New Website

We are pleased to officially announce the launch of our new website, which reflects our expanding role as a leading professional service provider to pharmaceutical, biotechnology and medical device companies.

 

We are highlighting our services for Advanced Therapeutic Medicinal Products (ATMPs – which include cell and gene therapies). As our business continues to expand, the goal with this new website is to provide clear visibility on our services and the cross-functional experts we have at HiTech Health to support your company’s needs. The website now details the wide range of capabilities we offer surrounding cell and gene therapy services and at our process development laboratory in Galway, Ireland. This state-of-the-art facility is open for business and we can perform activities ranging from process and analytical development to personalised training in the lab.

 

Visitors can explore the many services we offer to a diverse range of clients ranging from early stage pre-clinical companies to large multinational corporations. Our focus is on Operations (CMC) from early product development through to product launch, HiTech Health has the experts that can enable a successful product registration and launch. Our team have led the development, manufacture, and supply of multiple products including cell and gene therapies to patients in several countries. We provide quality and compliance, QP and regulatory expertise, our team can be an extension of your internal resources. You can read about these services and much more on the new website. Going forward, we will continue to communicate regularly on the latest industry news and insights, as well as upcoming events where you can meet some of our team.

Recent News

HiTech-Health awarded with government funding

HiTech Health awarded with €7m government funding for 'disruptive' project   HiTech Health and our partners, Relevium Medical and Professor Garry Duffy’s Laboratory at NUI Galway are honoured to receive €7 million from the Disruptive Technologies Innovation Fund...

Stay Up To Date

Connect with us to receive the latest HiTech Health and industry updates.