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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