Quality Associate

3 weeks ago

Dublin, Dublin City, Ireland Groupe ProductLife Full time

ProductLife Group is looking for aQuality Associate (RP) to join our dynamic and rapidly growing team:

Due to continued expansion, we are currently seeking a Quality Associate / RP to join our team in a well-established Consultancy. You would have proven success in your current role and an ambition to continually develop together with commercial awareness, a drive to innovate and be a key part of a growing company in the pharmaceutical space.

We hold our own MIA and ManA, and controlled drug licences, both in the UK and Ireland, to enable the importation of medicines into both the EEA and the UK. We also develop, implement and assist in the operation of WDA's for our Clients. As such the role of RP is a critical one within our business.

You will carry out the duties of a Responsible Person including

  • Ensuring the Quality Management system is implemented, maintained and subject to continuous improvement
  • Hosting and responding to regulatory and client audits
  • Ensuring all activities are compliant with regulatory requirements and terms of the licence
  • Assessing the impact of any deviations on product stored
  • Ensuring self-inspections are performed and that any subcontracted activities are suitably assessed
  • Provide support and input to the Regulatory Affairs team when required

The wider role of Quality Associate would cover

  • Providing support to the Quality Assurance Manager to ensure the efficient and effective operation of the Quality Management Systems (QMS).
  • To ensure the timely and accurate collection and recording of information within the QMS to allow Key Performance Indicators (KPIs) to be monitored.
  • To provide technical and quality system support to the wider business

You will work alongside the internal Quality team and our Clients to continually improve systems and maintain ongoing compliance ensuring that all products are manufactured and distributed in accordance with GMP/GDP and regulatory requirements.

Key Duties and Responsibilities:
  • To act and be named as a Responsible Person.
  • To ensure systems are in place that ensure products are transported, stored and distributed in a safe and secure manner
  • To ensure facilities used for the storage of medicinal products are suitable in terms of security, segregation, prevention of cross contamination and temperature
  • To ensure written procedures are in place for all GDP activities
  • Ensure that a system is in place to ensure all relevant audits have been conducted and that ongoing compliance is achieved by the use of risk assessment tools.
  • Ensure that all technical agreements are prepared and maintained in line with regulatory requirements and any changes to scopes of work.
Role Requirements:
  • Minimum of 3 years' experience within the pharmaceutical Wholesale Distribution sector working with a WDA QMS.
  • Currently named as an RP on a Licence with the HPRA, we would consider current Deputy RP's with a minimum of 6-12 months in that role
  • Knowledge of a range of dosage forms.
  • Thorough understanding of current GDP requirements.
  • Audit experience of GDP distribution facilities
Behavioral Competence:
  • Customer Focus: Good communication skills (verbal and written). Able to obtain information from customers to deliver the requirements of the role. Works to deliver best service to customers and manage their expectations.
  • Teamwork: Can work well in a multi-disciplinary team and across teams to deliver requirements of role.
  • Quality and Safety: Understands the quality standards required for the role and supports continuous improvement. Able to manage own performance to deliver on agreed objectives.
  • Flexibility: Able to adapt to meet the needs of the business at any point in time.
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