Qualified Person (QP)

Qualified Person (QP)

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.

 

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 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.

 

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//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 jobs@hitech-health.com and indicate the position title in the email subject line.

Applications to include a cover letter & CV. References should be made available upon request.

Location:

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.

Recent News

PMTC Spotlight – HiTech Health

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.

Senior QA Specialist

Senior QA Specialist

Senior QA Specialist

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 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 globally from the development to the launch and supply of products.

This is an exciting role for a highly motivated individual to join a growing organisation to work as a Quality Specialist supporting our businesses which stretch from quality and compliance services to our R&D and GMP facilities.

As Quality Specialist, you will be responsible, with support from management, for providing general Quality support for key functional areas (i.e. Process Development (PD), Validation, Quality Control, Supply Chain, Quality Assurance, Information Systems), ensuring that programs, policies and procedures are robust and in keeping with regulatory expectations and local requirements.

This permanent position is an exciting role for a dynamic individual to join a growing organisation with an increasing focus on advanced medicines including cell and gene therapy products.

The Quality Specialist reports to the Quality & Compliance Lead. The Quality Specialist will work across HiTech Health’s services, GMP and PD functions.

 

Principle Responsibilities:

  • Ensure that the Quality System at Hitech Health is maintained and developed in accordance with the MIA requirements and in response to changes in regulations and legislation.

  • Provide QA input into non-conformances/deviations/complaints investigations to ensure satisfactory root cause and identification and closure of effective CAPA’s.

  • Lead and/or participate in quality risk assessments and provide quality oversight to ensure risk assessments are effectively executed.

  • Perform QA review and approval of qualification lifecycle documents for facility & utilities, process equipment and laboratory instrumentation.

  • Respond to customer complaints and undertake investigations accordingly.

  • Review and approve PD batch records against approved specifications, quality standards and company procedures for release of product on behalf of HTH clients.

  • Review GMP batch records against approved specifications, quality standards, company procedures and regulatory filings prior to review and certification by HTH QP.

  • Write and/or review and approval of functional area documentation (SOPs, Work Instructions, technical reports and protocols).

  • Oversight and review of maintenance records (logbooks, cleaning records etc) of different functional areas.

  • Review and update of all QA documentation as required in accordance with GMP.

  • Provide support for regulatory and customer inspection readiness, execution and follow up.

  • Participate in internal audit and program and ensure internal audit programme is adhered to, an audit reports are actioned in a timely manner.

  • Lead HTH documentation management system and documentation control requirements.

  • Act in accordance with the company’s Guiding Principles and adherence to the company Code of Conduct.

  • Compliance to all local site policies, procedures and Environmental, Health and Safety regulations.

  • Communicating with clients and providing Quality and Compliance advice and support in line with project timelines.

  • Providing Clients with Quality and compliance support to ensure regulatory requirements are met.

  • Perform additional duties as required.

 

Qualifications and Experience:

  • Third level Degree in biology, chemistry, pharmacy or other relevant discipline.

  • Minimum 5 years’ experience in Pharmaceutical industry in a Quality role.

  • Sound awareness and understanding of pharmaceutical business, especially with regards to quality and GMP regulatory requirements.

  • Experience working with Quality Systems such as Deviations, Change Controls, Training, Supplier Qualification and Document Management systems required.

  • Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels.

  • High level of proficiency in English language (both spoken and written) required.

  • 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.

  • Thorough, diligent, good attention to detail.

  • Results driven and creative with a can-do attitude.

 

Salary Range: Negotiable. Salary is commensurate with experience and qualifications for this key position.

Working hours: Working hours will be 9 AM-5.30 PM daily. The nature of the work may require flexibility in working times.

Industry: Pharmaceuticals

Employment Type: Full-time

Start date: On completion of recruitment process.

To Apply: Please apply via jobs@hitech-health.com and indicate the position title in the email subject line.

Applications to include a cover letter & CV. References should be made available upon request.

Location: Dublin or Galway. Potential for Hybrid working

We reserve the right to re-advertise or extend the closing date for this job post.

HiTech Health is an equal opportunities employer.

Recent News

PMTC Spotlight – HiTech Health

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.

QA Specialist

QA Specialist

QA Specialist

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 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 globally from the development to the launch and supply of products.

This is an exciting role for a highly motivated individual to join a growing organisation to work as a Quality Specialist supporting our businesses which stretch from quality and compliance services to our R&D and GMP facilities.

As Quality Specialist, you will be responsible, with support from management, for providing general Quality support for key functional areas (i.e. Process Development (PD), Validation, Quality Control, Supply Chain, Quality Assurance, Information Systems), ensuring that programs, policies and procedures are robust and in keeping with regulatory expectations and local requirements.

This permanent position is an exciting role for a dynamic individual to join a growing organisation with an increasing focus on advanced medicines including cell and gene therapy products.

The Quality Specialist reports to the Quality & Compliance Lead. The Quality Specialist will work across HiTech Health’s services, GMP and PD functions.

 

Principle Responsibilities:

  • Ensure that the Quality System at Hitech Health is maintained and developed in accordance with the MIA requirements and in response to changes in regulations and legislation.
  • Provide QA input into non-conformances/deviations/complaints investigations to ensure satisfactory root cause and identification and closure of effective CAPA’s.
  • Lead and/or participate in quality risk assessments and provide quality oversight to ensure risk assessments are effectively executed.
  • Perform QA review and approval of qualification lifecycle documents for facility & utilities, process equipment and laboratory instrumentation.
  • Respond to customer complaints and undertake investigations accordingly.
  • Review and approve PD batch records against approved specifications, quality standards and company procedures for release of product on behalf of HTH clients.
  • Review GMP batch records against approved specifications, quality standards, company procedures and regulatory filings prior to review and certification by HTH QP.
  • Write and/or review and approval of functional area documentation (SOPs, Work Instructions, technical reports and protocols).
  • Oversight and review of maintenance records (logbooks, cleaning records etc) of different functional areas.
  • Review and update of all QA documentation as required in accordance with GMP.
  • Provide support for regulatory and customer inspection readiness, execution and follow up.
  • Participate in internal audit and program and ensure internal audit programme is adhered to, an audit reports are actioned in a timely manner.
  • Lead HTH documentation management system and documentation control requirements.
  • Act in accordance with the company’s Guiding Principles and adherence to the company Code of Conduct.
  • Compliance to all local site policies, procedures and Environmental, Health and Safety regulations.
  • Communicating with clients and providing Quality and Compliance advice and support in line with project timelines.
  • Providing Clients with Quality and compliance support to ensure regulatory requirements are met.
  • Perform additional duties as required.

 

Qualifications and Experience:

  • Third level Degree in biology, chemistry, pharmacy or other relevant discipline.
  • 3-5 years’ experience in Pharmaceutical industry in a Quality role.
  • Sound awareness and understanding of pharmaceutical business, especially with regards to quality and GMP regulatory requirements.
  • Experience working with Quality Systems such as Deviations, Change Controls, Training, Supplier Qualification and Document Management systems required.
  • Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels.
  • High level of proficiency in English language (both spoken and written) required.
  • 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.
  • Thorough, diligent, good attention to detail.
  • Results driven and creative with a can-do attitude.

 

Salary Range: Negotiable. Salary is commensurate with experience and qualifications for this key position.

Working hours: Working hours will be 9 AM-5.30 PM daily. The nature of the work may require flexibility in working times.

Industry: Pharmaceuticals

Employment Type: Full-time

Start date: On completion of recruitment process.

To Apply: Please apply via jobs@hitech-health.com and indicate the position title in the email subject line.

Applications to include a cover letter & CV. References should be made available upon request.

Location: Dublin or Galway. Potential for Hybrid working

We reserve the right to re-advertise or extend the closing date for this job post.

HiTech Health is an equal opportunities employer.

Recent News

PMTC Spotlight – HiTech Health

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.

EU Qualified Person (QP) Services in Cell & Gene Therapy (CGT)

EU Qualified Person (QP) Services in Cell & Gene Therapy (CGT)

In Europe, no batch of medicinal product can be released prior to certification by a Qualified Person (QP). Due to the rapidly evolving Advanced Therapeutic Medicinal Products (ATMP) landscape, it’s important to have up-to-date knowledge, expertise as well as years of experience managing Quality aspects of product and process development, to successfully release CGT product to clinical trials or to market in the EU, US, UK, and RoW.

 

QP batch release is required to be in accordance with EU requirements (Commission Delegated Regulation (EU) 2017/1569 and Regulation 536/2014) on Investigational Medicinal Products (IMP) covering both sterile and non-steriledosage forms. QP and Quality Services offered by Hitech Health include contractual QP services, for both general Quality consultancy and batch release, for short and long-term contracts.

 

The QP and Quality Services include:

  • Supporting and maintaining all aspects of Quality Management System (QMS) compliance.
  • Designing and implementing a robust supplier qualification program and effective management of this process.
  • Importation and QP Certification.

 

With Hitech Health holding the Manufacturer’s/Importer’s Authorisations (MIAs) for the importation and QP certification of both Commercial and Clinical products within the EU, CGT products can be imported and released to EU clinical trials in a matter of months.

 

Hitech Health has QPs specialising in the CGT and ATMP field and can offer quality support for the successful release of your CGT product. By partnering with us and working with our experienced cross-functional team under our already approved MIAs, you reduce personnel and regulatory cost, thereby making considerable financial and time savings in getting your product to the clinic or market.

 

To learn more about our cell and gene therapy services by clicking here

Find us on LinkedIn

Contact: info@hitech-health.com

HiTech Health Attending Phacilitate’s Advanced Therapies Week 2023 in Miami, USA

HiTech Health Attending Phacilitate’s Advanced Therapies Week 2023 in Miami, USA

Hitech Health’s Cell and Gene Therapy Operations Manager Aoife Duffy and Global Head of Commercial Clare O’Sullivan will be attending Phacilitate’s Advanced Therapies Week 2023 in Miami from January 17th – 20th. Advanced Therapies Week is the destination for developers, investors and solution providers whose goal is to bring cell and gene therapies to patients. We are really looking forward to the event and will be available for partnering meetings to discuss how we can help your advanced therapy processes and reach your goals.

 

Schedule a meeting with our experts today: info@hitech-health.com

 

Learn more about our services here: www.hitech-health.com