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Quality Assurance Manager, ANZ Market

Quality Assurance Manager, ANZ Market

Gilead Sciences Singapore Pte. Ltd.Singapore, Singapore
20 days ago
Job description

Description

s are in place for local affiliate personnel working on quality / distribution matters.

  • Establishes and maintains the Affiliate Quality Manual and GMP / GDP procedural documents.
  • Establishes and maintains the Quality Agreement with 3PL / 4PL and local GMP / GDP related suppliers / service providers, as required.
  • Reviews Annual Product Quality Reports (if applicable)
  • Ensures shipping conditions match the product license / product label particulars and transporters are appropriately qualified.
  • Ensures premises and / or equipment used are reviewed regularly to ensure they are adequate to allow the handling, storage, and distribution of medicinal products in a manner that ensures the maintenance of product quality.
  • Supports Customer Services with enquiries of a GDP nature such as delivery issues, transportation conditions, disputes, etc.
  • Working with 3PL / 4PL, provides guidance on supply related issues.
  • Arranges authorized relabeling / repackaging in cooperation with 3PL / 4PL (where applicable)
  • Supports the management of quality and distribution complaints.
  • Supports the investigation of fraudulent and counterfeit medicinal products.
  • Manages product return and destruction.
  • Manages local recalls and participating in supplier’s recall challenge or perform local mock recall, as needed.
  • Qualifies and manages local 3PL / 4PL and supports audit of 3PL / 4PL.
  • Qualifies and manages local GMP / GDP related suppliers / service providers, auditing and approving these according to local requirements.
  • Assure customers validations and adequate records compliance to Gilead QA requirements are established and maintained for all local distributors / customers.
  • Host and lead Health Authority inspections and corporate audits.
  • Manages the Affiliate self-inspection program.
  • Supports audit of distributor (where applicable).
  • Collaborates with RA to implement activities for new product launch and product life cycle management.

Knowledge, Experience & Skills :

  • Highly organized individual with a strong work ethic and ability to work flexibility and independently.
  • Demonstrates proficiency in Good Manufacturing Practices (GMPs) and / or Good Distribution Practices (GDPs) and knowledgeable about the specific requirements for Australia and New Zealand.
  • Demonstrates proficiency in application of QA principles, concepts, industry practices, and standards.
  • Demonstrates proficiency in Quality Systems processes (Deviation, CAPA, Change Control, Complaints, etc.)
  • Demonstrates a knowledge of regional / local regulatory requirements and industry standards.
  • Demonstrates strong verbal, written, and interpersonal skills in English.
  • Demonstrates proficiency in Microsoft Office applications, particularly, WORD, Excel, PowerPoint, and Teams. Familiarity with technology platforms such as Veeva Vault, SAP ERP, etc.
  • Working knowledge of Risk Management tools (e.g., Failure Mode Effects Analysis (FMEA) is preferred.
  • Typical Educational Experience & Competencies

  • Bachelors’ degree and 7+ years of relevant experience in a GMP or GDP environment-related field (pharmaceutical or pharma-related)
  • Masters’ degree and 5+ years of relevant experience in a GMP or GDP environment related field (pharmaceutical or pharma-related)
  • Ability to work on own initiative as well as display strong teamwork skills.
  • Demonstrates clear personal responsibility for own work, in terms of both the quality of the work and the manner in which it is performed. ‘
  • Ability to support change and respond to change requirements by continually striving to improve working processes and systems, consistent with the organisational strategy.
  • For Current Gilead Employees and Contractors :

    Please apply via the Internal Career Opportunities portal in Workday.

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    Quality Assurance • Singapore, Singapore