Quality Associate

2 weeks ago

Northwich, United Kingdom Dechra Pharmaceuticals PLC Full time
Summary

Thanks for checking out our vacancy, we're delighted you want to learn more about Dechra.

Dechra are a growing, global specialist within the world of veterinary pharmaceuticals. Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide.

Here at Dechra, our values are embedded within our culture and thrive within our family of almost 2000 colleagues globally. From manufacturing to marketing, (D)edication, (E)njoyment, (C)ourage, (H)onesty, (R)elationships and (A)mbition are at the heart of our everyday operations and the way we do business

The Opportunity

Dechra Pharmaceuticals are looking for a Quality Associate professional to join our Quality team at our Northwich headquarters.

Reporting into the Quality Manager- External Network (UK/EU), you will be responsible for ensuring that the CMO initiated Quality Management System documents are fully evaluated, approved and logged in Dechra's electronic quality document management system.

You will be involved in the coordination between Dechra's internal network, external network, Good Distribution Practice (GDP) and Divisional Quality teams of supplier approval activities and that Dechra's External Network QMS activities, are tracked, trended, reported and progressed to timely closure.

This is a great role to learn from industry specialist at a global pharmaceuticals manufacturing organisation.

Main Responsibilities

So, what will you be doing? This role has a broad and varied remit and the successful candidate will have responsibility for duties including:

  • Initiate and coordinate contract manufacturing organisation (CMO) document review, approval and upload in Dechra's electronic quality document management system (Veeva).
  • Initiate and coordinate change control review and approval by subject matter experts (SME's) and feedback to CMOs.
  • Support the preparation of key performance indicators (KPI) reports to drive closure of Quality management System (QMS) activities.
  • Request and coordinate the review of CMO stability data in Veeva by SMEs.
  • Request and coordinate the review of CMO product quality reviews (PQRs) in Veeva by SMEs.
  • Initiate new Quality / Technical Agreements (QTA's) based on approved templates, coordinate the require and approval of QTA's by SMEs.
  • Manage the upload of QTA's into Veeva, Initiate and coordinate the periodic review of QTAs.
  • Coordinate with Internal Network Supplier Approval teams, External Network Quality Specialists, Divisional Quality and GDP Quality on the preparation and maintenance of a global regulatory relevant approved supplier list.
  • Work with all parties concerned to identify the team responsible for supplier approval.
  • Coordinate with CMO's and auditors on provisional audit dates, support audit preparation by liaising with internal / external network and Divisional functional stakeholders.
  • Support the audit team in travel arrangements as necessary.
  • Support the upload of audit deliverables in Veeva, log agreed audit observations in centralised tracking logs, chase CMO's as required for audit responses.
  • Log CMO corrective and preventative actions (CAPAs) into centralised tracking logs, track CAPA completion for critical / major observation.
  • Support the generation of audit closure documentation.
  • Manage the update External Network and global approved supplier lists.
  • Initiate and coordinate the review approval and update of External Network supplier risk assessment documentation.
  • Coordinate and support the preparation of Quality Review slides
  • Support requests for CMO data.
  • Work with the Divisional Quality team to coordinate impact assessments of new and emerging regulations in the external network.
  • Coordinate assessment and feedback from CMOs of those changes impacting CMOs.
  • Support the creation of reports based on established templates and data for Quality Specialist Review and approval.
  • Support Recall Coordinators in the preparation of documentation and the consolidation of data.
  • Liaise with the product defect intake teams in order to ensure GDP and product defect complaints are appropriately escalated and investigated reviewed and accepted by Quality Specialists and other functions as required.
Ideal Candidate

Here at Dechra we pride ourselves on being an inclusive employer and we embrace candidates from all walks of life. We're particularly keen to hear from those who have/are:

  • Experience of working within a QA setting in a pharmaceutical environment.
  • Detail oriented and data driven.
  • Diplomatic with good listening skills, confident and effective communicator.
  • Proactive and solutions driven, with the ability to work to strict deadlines with a high level of accuracy.
  • Fully IT literate: Microsoft Outlook, Word, Excel, Power point.
  • Highly self-motivated with strong inter-personal skills.
  • Ability to work with cross-functional teams on new process projects and process improvements.
  • Ability to prioritise work and handle multiple deadlines.
  • Sciences based "A" levels / Bachelor degree (Pharmacy, Chemistry, Biochemistry or equivalent)

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