Senior Quality Specialist

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Job Title: Senior Quality Specialist
Location: Gurgaon, India

About the role:

• Perform quality operations for Takeda in India to ensure its compliance with local regulatory authority and Takeda’s global requirements for importation, local testing, repackaging, redressing, release, storage and distribution of Takeda products.
• Perform/support activities to 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/support quality activities and resolve quality issues to support the continuous supply of Takeda products in India in compliance to local regulatory authority and Takeda’s global requirements.

How you will contribute

• Perform/support local quality activities related to the importation, release, storage, repackaging and distribution of Takeda products in India timely and according to the local regulatory authority and Takeda’s global requirements so as to support the continuous provision of quality complaint Takeda products in India.
• These activities include but are not limited to: Batch documentation review for importation, coordinating Local product testing (document, sample submission & on time temperature evaluation, necessary document review, release in ERP system), Redressing records review, document creation/maintenance, product transfer temperature data review, temperature evaluation, necessary document review, release in ERP system).
• Perform/support activities for Takeda in India to maintain a systematic, effective and efficient local Quality Management System (QMS) as per local regulatory authority and Takeda’s global requirements. The QMS includes but are not limited to: documentation creation, document maintainenance & control, Maintenance of logs, SOP writng, personnel training management, product, product complaint handling, change control, deviation/CAPA, gap assessments, 3PL activities support.
• Handling of electronic QMS systems like Trackwise, Training systems and electronic documentation management system.
• Any other tasks as assigned.

Technical/Functional (Line) Expertise

• The technical/functional expertise for personnel includes good understanding of GMP and GDP, quality improvement methodologies and regulatory requirements in Pharmaceutical industry.

Leadership

• Strong communication and interpersonal skills, ability to learn and deploy new processes.
• Effective stakeholder management, drive continuous improvement.
• Leverage technology and data to drive quality initiatives.

Decision-making and Autonomy

• Effective decision making abilities under complex situations
• Know -how when to escalate Quality issues.

Interaction

• To interact with country level stakeholders viz. SC, Franchisee, RA, Regional and Global teams. Ability to manage Regional and Global teams efficiently.
• Ability to impact Business teams of LOC.
• External stakeholders viz. Suppliers, Govt. Labs.
• Good communication skills – both written and verbal.

Innovation

• Self starter
• Disseminating best practices, lessons learned, and successful quality improvement initiatives
• Exploration and implementation of new approaches
• Willingness to experiment with new ideas and methodologies, while carefully considering potential risks and benefits to drive continuous improvement

Complexity

• .Imported Takeda products, Manage networking of suppliers

What you bring to Takeda:

• Minimum 5-7 years’ experience in Pharmaceutical Company in 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).
• Sound knowledge and experience in working with cGMP and quality management system elements and guidelines (e.g PIC/s, ICH, ISO9001 or ISO 13485) and cold chain product repackaging.
• Experience in managing supplier audits, internal audits, regulatory authority inspections.
• Ability to work independently and identify compliance risks and escalate when necessary
• Good sense of urgency and strong follow up Scientific Knowledge
• Travel 25 to 35% to a local warehouse within Gurgaon