GMP Supply Chain Quality Specialist

1 week ago

Glasgow, Glasgow City, United Kingdom Curia Full time

Curia has an exciting opportunity to join our Quality Assurance team based at our Glasgow, G20 site in the role of GMP Supply Chain Quality Specialist. This is a technical position, with the responsibility to partner across functions on our site to provide support. This specialist role raring arises and it would suit a candidate who has a passion for auditing and compliance adhering to GMP, MHRA, COSHH and Health and Safety regulations.

At Curia, our Quality Assurance Team is critical to ensuring all activities, suppliers and audits are carried out to the gold standard of GMP, Quality; and Quality Management Systems and regulations are achieved. As Curia Scotland is part of Curia Global, this role also collaborates globally on projects.

Responsibilities include and are not limited –

Maintain, and monitor a complex network of suppliers supporting GMP sterile manufacture across Phase I, II, and III, in accordance with EudraLex Volume 4 Chapter 7, including:

  • Active risk management.
  • On-site supplier audits for critical suppliers, including analytical testing labs, warehousing, materials manufacture, sterilisation sites and more.
  • High-quality report writing for supplier risk assessments and audits delivered in a timely manner.
  • Maintain data driven risk matrices, both locally and globally.
  • Maintain an Approved Supplier List for the site, including all materials and services used across a range of applications with appropriate risk mitigation for each.
  • Implement and maintain, where assessed as necessary, supplier Quality Technical Agreements and Non-disclosure agreements.
  • Maintain strong, effective working relationships with clients, domestically and internationally.
  • Maintain physical and digital records supporting supply chain compliance, and ensure coherence and accuracy of all records.
  • Plan, execute and review the supplier qualification program independently, including liaising with internal and external stakeholders, planning audit agendas, writing comprehensive audit reports, and monitoring and closing out post-audit activities where necessary.
  • Undertake a critical review of third-party audit reports, and assess associated documentation in a risk proportionate manner.
  • Liaise, and closely integrate with, a global team of auditors and managers to ensure compliance with a Globally administered supplier management system, providing ongoing support for other networked sites.
  • Escalate, where necessary, perceived supply chain risks, and implement mitigating actions to reduce supply chain risk.
  • Work closely with project leads, warehousing and procurement staff to ensure timely and compliant supply of appropriate materials to support GMP manufacture and release.
  • Manage vendor complaints and change notifications as part of an ongoing supplier risk management programme.
  • Support internal audits, and provide ongoing training and support for other internal auditors on site.
  • Actively manage the training of audit qualified staff to maintain a strong bench of SMEs capable of supporting or executing the audit program.
  • Effectively manage own expenses, and travel accommodation, when traveling off site.

Necessary Skills –

  • Minimum 3 years background supporting manufacture of sterile GMP medicines.
  • A good understanding and familiarity of EudraLex Volume 4, ISO9001:2015 as audit criteria.
  • Skilled auditor with a strong history operating in a GMP setting.
  • Align with Curia Values to act with integrity, respect and accountability at all times.
  • Experience dealing with intense environments diplomatically, and respectfully.
  • Excellent verbal and written communication skills, over a broad range of technical subjects.
  • Strong proficient presentational skills.
  • Good time management skills, motivated to reach deadlines and partner with others
  • Right to work in UK with a Full UK Driver's license and flexibility to travel is necessary.

Desirable skills –

  • IRCA Auditor Certification or equivalent strongly preferred.
  • Familiarity with ICHQ guidelines, as well as FDA CFR 20 and 21.

Hours: 8-hour shift including breaks, with a flexible starting and finish time between 8am and 7.30pm, Monday to Friday, on call rota around 1 in 5, this role requires flexibility to travel

Excellent employee benefits provided on request.

Curia (Scotland) Limited is committed to fostering a diverse and inclusive workplace where all perspectives are valued and respected. We proudly support equal opportunity and are an affirmative-action employer, welcoming applications from all qualified individuals. We consider all applicants for employment without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, genetic information, disability, veteran status, or any other protected status.

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