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Senior Quality Specialist
1 month ago
As a Senior Quality Specialist at Takeda, you will play a critical role in ensuring the compliance of our operations in India with local regulatory authorities and our global requirements for importation, local testing, repackaging, redressing, release, storage, and distribution of our products.
Key Responsibilities:
• Perform quality operations to ensure compliance with local regulatory authorities and Takeda's global requirements.
• Develop, implement, and maintain a systematic, effective, and efficient local Quality Management System (QMS) as per local regulatory authority and Takeda's global requirements.
• Perform and support quality activities to resolve quality issues and ensure the continuous supply of Takeda products in India in compliance with local regulatory authorities and Takeda's global requirements.
Requirements:
• Minimum 5-7 years' experience in a Pharmaceutical Company in a quality function with GMP manufacturing plant environment of sterile Pharmaceuticals and 1-2 years in commercial Quality office environment.
• Good knowledge and experience in working on the development, implementation, and maintenance of a Quality Management System compliant to local India regulatory requirements on Good Storage Practice (GSP) and Good Distribution Practice (GDP) and Drugs and Cosmetics Act, Schedule M, and WHO guidelines.
• Good knowledge and experience on managing/performing quality operation activities and the regulatory requirements for the importation, repackaging, product release, storage, and distribution of pharmaceutical products (including solid dose, biologics, and cold chain).
