Supplier Quality Specialist - Bathgate, United Kingdom - Catalent

Catalent
Catalent
Verified Company
Bathgate, United Kingdom

1 week ago

Tom O´Connor

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Tom O´Connor

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Description
Catalent Pharma Solutions are looking to recruit a
Supplier Quality Specialist to join our team. The role will see you as an integral member of the CDS Quality Network.

The position will support harmonization and centralization of network quality programs as well as support initiatives for the Supplier Quality program including supplier qualification, performance monitoring, recall, regulatory compliance and continuous improvement across the Network.


The Role

  • Manage the CDS Global and Network Approved Supplier List (ASL)
  • Monitor and track supplier performance by gathering relevant data and capturing into relevant systems
  • Participate / lead continuous improvement activities related to quality across the Catalent Global CDS network and CDS Global Programs
  • Plan, conduct and report external audits and assessments in line with procedures in support of the Global Network Approved Suppliers.
  • Complete and assist in completion of Supplier Quality Agreements, Supplier Questionnaire Audits, Risk Assessments, Supplier Complaints, Supplier Notifications, Risk Control Plans, Change Controls, Actions and Followup's.
  • Ensure supplier records are initiated and maintained for all Network suppliers including audits, assessments, and quality agreements
  • Assist in maintaining the CDS external audit schedule and approved supplier list
  • Ensure corrective action activities associated with all audit observations are agreed and completed in a timely manner.
  • Manage the recall program and conduct product recalls as it relates to the Comparator Program and Network Suppliers.
  • Manage and conduct Supplier Notifications for Global Supplier Quality Management and Network Supplier Programs including evaluation for potential impact to internal processes and client commitments
  • Manage and support supplier and material usage assessments for Global Supplier Quality Management and Network Supplier Programs.
  • Manage and conduct the Global Supplier Quality Management Monthly and Annual license reviews for Comparator, Depot and Controlled Drugs
  • Manage regulatory license notifications and conduct evaluation for potential impact as it relates to Global Supplier Quality Management
  • Manage and conduct direct from manufacturer approvals for the Global Supplier Quality Management
  • Provide JDE administrative support as it relates to Global Supplier Quality Management and Network Supplier Programs
  • Support/participate or lead in improvement activities and key initiatives and programs for the Global Supplier Quality Management and Network Supplier Programs
  • Any other tasks deemed appropriate to support the Global Supplier Quality Management or Network Supplier Programs
  • A Bachelor's Degree in a scientific or engineering discipline with at least two years of experience in pharmaceutical quality, or an equivalent combination of education and experience.
  • Prior Supplier Auditing experience and experience in writing supplier audit reports, certified auditor or lead auditor credentials are preferred.
  • Demonstrable experience and sound knowledge of GMP/GDP/GCP regulations, especially those related to comparator sourcing, wholesaler licensing, third party storage and distribution
  • Ability to work independently with strong goal orientation and sense of responsibility
  • Competence in both written and verbal communication
  • Strong process improvement mindset, strategic business perspective and critical thinking capability
  • Strong followup skills and attention to detail
  • Demonstrated project management skills with an ability to prioritize, plan, evaluate & execute deliverables for established tactical goals.
  • Demonstrated ability to lead crossfunctional teams.
  • Ability to influence and make recommendations at multiple levels of the company
  • Ability to be decisive when required on product quality issue's to ensure compliance
  • Ability to travel both domestic and abroad to Catalent sites and supplier locations as required, approximately 25% travel.
  • Excellent verbal and written communication and presentation skills with the ability to comprehensively read, write, and speak English.
  • Physically located in the EU/UK region
  • Located within a commutable distance to International Airport.
  • Ability to conduct position responsibilities in a remote working environment involving use of IT equipment for extended periods.

Catalent's standard leadership competencies

  • Leads with Integrity and Respect
  • Delivers Results
  • Demonstrates Business Acumen
  • Fosters Collaboration and Teamwork
  • Champions Change
  • Engages and Inspires
  • Coaches and Develops

Catalent offers rewarding opportunities to further your career Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to
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