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External Supply Quality Assurance (ESQA) Manager –

Keywords / Skills : External Supply Quality Assurance (ESQA) Manager â€ÂÂÂÂÂÂÂ"

3 - 5 years
Posted: 2019-01-03

Software Engineer/ Programmer
Posted On
3rd Jan 2019
Job Ref code
Job Description
Job Description :

The Contingent Worker - External Supply Quality Assurance is responsible for:
  • Supplier/Contractor Management: Ensure suppliers/contractors have applicable quality systems and comply with GMP/regulatory requirements and Zoetis expectations for the product. Oversee GMP activities at suppliers/contractors, such as Change Control, Deviation Management, Lot Approval, Complaint Handling, Annual Product Reviews (APR), Stability Study, Validation Approval, Audit Support, Quality System Support and Metrics Review, etc.
  • New Product Introduction (NPI): Support the selection, audit and evaluation of potential contractors in the process of NPI. Assess the quality and compliance status at contractors prior to sourcing decision. Carry out due diligence Quality audits as directed and make recommendations on suitability of contractors and new business opportunities.
  • Product Transfers: Act as QA support to Product transfer teams and advise such teams on Zoetis expectation regarding process validation and Analytical Method Transfer Exercise (AMTE) performed at contractor. Supply QA approvals as required of the Transfer Plan and other activities, eg. Validation.
  • Regulatory: Support or conduct Regulatory compliance assessment at contractor. Support the process of documentation retrieval and collation to support Manufacturing Authorization renewals. Assess risk for Annual Reportable changes and CBEs and communicate/approve risk assessments when required. Act as QA focal point for regulatory communications and changes.
  • Contract Process: Support the Supply Agreement contract process by developing, negotiating the Quality Agreement and co-ordinate the quality document agreement and approval route ensuring all key quality requirements are met. Maintain established Quality Agreements with contractors.
  • Other Contractor Assessments/Regulatory Inspections and Interactions: Facilitate and participate in assessment programs of contractors. Act as the Zoetis representative in the event of an external regulatory inspection involving Zoetis product at the contractor. Support contractor to develop and implement audit action plans, and track contractor CAPA plans to completion.
  • Development and Implementation of ESQA Guidelines & Policies: Contribute to the maintenance of the ESQA Quality System. Participate in developing ESQA Guidelines to ensure consistency of contractor standards across Zoetis. Ensure a consistent approach to the interpretation and implementation of GMP standards and Zoetis expectations.

  • Level of Education: Sc., B. Pharm, M. Pharm or equivalent degree
  • Experience: Minimum 3-5 years of relevant pharmaceutical industry experience in QA and/or Manufacturing
  • Languages: Fluency in English, Any other language is an asset
  • Computer skills: Advanced user-level of MS Office applications
  • Profile: Ideal candidates should possess the following skills or have experience in the following:
  • Experience that may include multifunctional, multi-site or other functional experience
  • Working with multicultural, cross-functional work teams
  • Experience in Quality Compliance functions
  • Working knowledge of Quality Systems and Risk Management
  • Knowledge of US FDA / EU GMP requirements impacting manufacturing operations
  • Ability to work independently and in teams

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