Associate Quality Assurance Manager

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Job Description

OBJECTIVE:

The responsibility of this role is to maintain continuous improvement of quality as a foundation of Takeda’s Corporate Vision, Mission and Values and ensure all of the local GxP activities are in compliance with Health Authority requirements, Takeda requirements and standards.

ACCOUNTABILITIES:

1.         Maintain a comprehensive Quality Management System (QMS) to achieve Takeda’s quality objectives. These include but not limited to:

• Execute QMS associated activities such as customer complaints handling, deviation management, CAPAs, change control management and quality risk management etc. ensuring they are managed timely and effectively.
• Manage documentation and training curricula.
• Support preparation for Quality Council meetings.
• Monitor quality-related metrics ensuring their compliance with the set targets.
• Coordinate self-inspections and support regulatory authorities’ inspection / Takeda internal audits.
• Coordinate recall / mock-recall
• Support supplier quality management.
• Support local medical quality governance activities.

2.          Manage product disposition and prepare Product Quality Review

3.         Support cross function activities / projects when required ensuring quality regulations and requirements are followed. 

4.         Support in driving Quality Culture and implementing quality risk management.

5.         Communication with the health authorities in timely and effective manner ensuring smooth release of products and efficient resolution of critical quality issues requiring health authorities’ approval.

QUALIFICATIONS:

• Bachelor or Master Degree, major in medical, science, bio-tech, pharmacy or related fields is preferred.
• At least 3 years’ working experience in the pharmaceutical/bio-pharm/food industries is preferred.
• Experienced in building relationships and working with in-house drug manufacturing, CMOs and auditing vendors is preferred.
• Demonstrate enthusiasm in quality management.
• Fluent in English & Local Language
• Good interpersonal communication, negotiation and strong presentation skills.
• Well ability to use IT tools, such as Word, Excel, etc. and interface effectively with variety of technical platforms.
• Well ability for documentation and maintenance of the dossiers

TRAVEL REQUIREMENTS: upon requirement

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