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Director of Quality

3 months ago

Morpeth, United Kingdom Piramal Pharma Solutions Full time

This role has accountability for the management of the Quality Operational functions at Piramal Pharma Solutions Morpeth Site.​


Hit Apply below to send your application for consideration Ensure that your CV is up to date, and that you have read the job specs first.

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The role has responsibility for tactical and operational management of the Quality Assurance and Quality Control functions and is part of the Site Leadership Team.​

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The role will maintain and develop the Quality Operations function in line with regulatory, industry and corporate expectations whilst ensuring strategy is effectively linked to long and short term business aims and objectives.​

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The role incumbent will provide strong leadership and direction in the application of performance management and continuous improvement in all aspects of the Quality function at the Morpeth site​

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Scope includes, but not limited to, ensuring the appropriate application of​

  • The manufacture of medicinal products for human use through:​
  • Manufacturing and Importation Authorisation​
  • Manufacture of Specials​
  • Manufacture and Importation of Investigational Medicinal Products​
  • Acting as the Quality and regulatory focus for products manufactured under Morpeth Marketing Authorization Holder (Project Agile)​

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The role has responsibility for acting as an associate of the EU Quality function in terms of implementing business goals and processes including delivery/implementation of CQA initiatives, CQA Policies/Guidelines and the CQA Audit programme, at a site level.​

Role

To set, drive and consistently review internationally recognizable and GMP compliant standards appropriate to the CDMO pharma business in the following areas: - Materials Control, Manufacturing Control, Packaging & Labelling Control, Facilities & Equipment Control, Quality Control, Quality Management Systems and change management​

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  • To collaborate with Site Leadership team and all department heads to ensure regulatory compliance, cGMP and quality assurance are a shared responsibility.​
  • To ensure an effective Quality function at the Morpeth site, facilitating the long and short term business aims and objectives. ​
  • To manage and host all regulatory and strategic customer audits.​
  • To be an effective associate of the Regional Quality team, taking part in CQA initiatives as needed.​
  • Identification, remediation and escalation of all compliance issues with the potential to cause critical or major audit observations from the Morpeth site, to the UK & EU Regional Quality Director.​
  • Ensure the Pharmaceutical Management System, Quality resource and capabilities available at the Morpeth site supports the delivery of projects and new business.​
  • Manage the Morpeth Quality Management Review process and appropriate action plans, including functional escalation​
  • Lead innovation and improvements of processes in relation to the Pharmaceutical Quality Systems employed at Morpeth.​
  • Ensure all activities comply with the requirements of the manufacturing and distribution licenses, national and international guidelines appropriate to the destination market, marketing authoritarians and Clinical Trial Authorizations.​
  • Ensures adherence of all cooperate guidelines and ESH requirements​
  • To drive compliance with the requirements of ICH Q10 at Morpeth, ensuring that the following criteria are delivered:-​
  • Senior management has the ultimate responsibility to ensure an effective Pharmaceutical Quality System is in place, adequately resourced and that roles, responsibilities, and authorities are defined, communicated and implemented throughout the organisation​
  • Senior management’s leadership and active participation in the Pharmaceutical Quality System is essential. This leadership should ensure the support and commitment of staff at all levels and sites within the organisation to the Pharmaceutical Quality System​
  • There should be periodic management review, with the involvement of senior management, of the operation of the Pharmaceutical Quality System to identify opportunities for continual improvement of products, processes and the system itself​
  • The Pharmaceutical Quality System should be defined and documented. A Quality Manual or equivalent documentation should be established and should contain a description of the quality management system including management responsibilities​

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