Immediate Start: Qualified Person QP New

2 weeks ago

Longford, Ireland CPL Full time

Qualified Person – QP

On behalf of my client, a consultancy company for the Life Sciences industry we have a new role for a Qualified Person to join the team.

We are seeking a highly experienced and driven Qualified Person to join the team. This is a permanent full-time opportunity

My client strongly believes that a supportive and healthy work life balance is critical for their team to be happy and successful, and so they offer truly flexible working hours as standard. This applies to both when and where you work, with autonomy and trust given to everyone in their team from day 1.

Purpose of Job

· To fulfil the Company’s requirements with respect to Qualified Person services, in accordance with Annex 16.

· To provide input for development and implementation of the Quality Management System

· To ensure compliance in terms of GMP

· To host regulatory agency inspections and customer audits

· To support internal and external quality audits as required

· To provide training in GMP as required

· Some IMP experience in terms of bringing IMPS into Europe and dealing with different scenarios would be hugely beneficial. Some sterile or biologics experience would also be a big advantage.

Main Duties and Responsibilities

- To perform the Qualified Person duties in accordance with Article 51 of Directive 2001/83/EC as amended and Clinical Regulation 536/2014 These duties shall include:
- Ensuring all activities associated with manufacture and testing of the medicinal product have been conducted in accordance with the principles of GMP
- Ensuring the starting materials used comply with the requirements, the supply chain is known, and audits have been carried out.
- Ensuring that the manufacturing processes and testing methods are validated and in accordance with the marketing authorisation.
- Ensuring changes have been assessed and completed accordingly
- Ensuring that the requirements of the product registration and of the manufacturer’s licence have been met
- Ensuring that the legal requirements for nationally manufactured and imported products have been met.
- For products imported from outside the European Union (EU) or European Economic Area (EEA) the QP should ensure testing within the EU/EEA to requirements of the product registration and any other tests to assure quality of the products, unless a Mutual Recognition Agreement exists between the EU and the third country concerned

Qualifications and Role Requirements

- Degree in a scientific discipline: Chemistry, Pharmacy, Pharmaceutical Chemistry or biology.
- A minimum of 5 years pharmaceutical industry experience
- Attainment of the status of Qualified Person in accordance with the HPRA’s educational requirements, experience, training, and licensing (compliance with the requirements of Directive 2003/94/EC)
- The QP shall reside and operate in the EEA
- The QP should have a complete programme of Continuous Professional Development (CPD)
- The QP should have skills for the management of the quality functions of the Company
- Ability to work cross functionally within the Company and apply GMP and associated legislation

-

For full details & Job Spec email your CV to [email protected] or call Tina at +353 1 2784701

Thornshaw Scientific is a division of the CPL Group www.thornshaw.com

#LI-TD1

  • Qualified Person QP

    6 days ago

    Longford, Ireland Cpl Full time

    Qualified Person – QPOn behalf of my client, a consultancy company for the Life Sciences industry we have a new role for a Qualified Person to join the team.We are seeking a highly experienced and driven Qualified Person to join the team. This is a permanent full-time opportunityMy client strongly believes that a supportive and healthy work life balance...

  • ▷ (Immediate Start) Field Sales Representative - 2k sign on bonus

    2 weeks ago

    Longford, Ireland Prepay Power Full time

    Field Sales Representative - 2k sign on bonus Department: Field Sales Employment Type: Full Time Location: Longford Compensation: €32,000 - €50,000 / year Description The Field Sales Representative will generate new customer leads through face-to-face sales - helping prospective customers to analyse and take control of their energy costs. What's in it...

  • RPN required for CAMHS Midlands Laois/Offaly/ Longford

    2 weeks ago

    Longford, Ireland Nurse on Call Full time

    RPN required for CAMHS Midlands Laois/Offaly/ Longford / Westmeath RPN required to work in Longford/Westmeath/ Laois/ Offaly Child and Adolescent Mental Health Services Position will be based in Mullingar Monday – Friday Hours: 9am -5pm Immediate start 3 months with a view to extension To note your interest,

  • Recruitment Consultant

    1 week ago

    Longford, Ireland ProSource Group Full time

    We at ProSource Group are seeking a Recruitment Consultant to become part of our growing team within our Longford Office. Who we are: ProSource Group is a leading recruitment agency based in Longford. We are an ambitious, growing company where we put an honest focus on company culture and employee happiness. This is a distinct opportunity to join an...

  • Sales Executive

    2 days ago

    Longford, Ireland September Consulting Ltd Full time

    Overview Location: Navan, you will cover Navan area and surroundings area but not much further. Are you a motivated sales professional with a strong commercial insurance background? My client is looking for a driven individual to join their team in a client visits/on-the-road advisory role, handling larger policies and new business opportunities. This is...

  • ▷ (15h Left) Payroll Specialist

    2 weeks ago

    Longford, Ireland Total Solutions Full time

    My client, a well-established professional services firm, is currently seeking an experienced Payroll Specialist to join their busy team based in Longford, Co. Longford Position Overview As the Payroll Specialist, you will play a key role in ensuring the accurate and timely processing of client payrolls on a weekly, fortnightly, and monthly basis. Working...

  • Maintenance Technician

    2 minutes ago

    Longford, Ireland ESS Ltd. Full time

    Main Duties : Electrical and Mechanical trouble-shooting Electro-mechanical repairs to high-speed, PLC-controlled plant, handling and packaging equipment, also pneumatic and hydraulic control systems Input to and carry out Preventive & Predictive Maintenance Routines Support Production Team in achieving targets Closely monitor line and machine performance...

  • Midlands Occupational Health Service based in Tullamore, Co-Offaly.

    4 days ago

    Longford, Ireland Nurse on Call Full time

    Midlands Occupational Health Service based in Tullamore, Co-Offaly. Location Grade Staff Nurse Experience Be registered in the general division of the live Register of Nurses maintained by Nursing & Midwifery Board Ireland. Candidates must possess the requisite knowledge and ability, (including a high standard of clinical and administrative capacity), for...

  • Site Foreman

    6 minutes ago

    Longford, Ireland Connect Recruitment Full time

    Our client are seeking an experienced and highly motivated Site Foreman to oversee daily operations on a housing project in Balbriggan, Co. Dublin. The successful candidate will be responsible for supervising on-site personnel, coordinating subcontractors, maintaining site safety, ensuring quality workmanship, and delivering the medium sized project on time...

  • Social Care Worker Residential ID New

    1 week ago

    Longford, Ireland CPL Full time

    Cpl Healthcare are currently seeking Social Care professionals to join a reputable service supporting individuals with disabilities in a residential service in Longford. We require residential Social Care Workers to provide high-quality care to the service users, promoting independence and person-centred planning, contributing to the service's day-to-day...