Job Description
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I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionJob Title: Senior Quality SpecialistLocation: Gurgaon, IndiaAbout 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 contributePerform/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) ExpertiseThe technical/functional expertise for personnel includes good understanding of GMP and GDP, quality improvement methodologies and regulatory requirements in Pharmaceutical industry.LeadershipStrong 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 AutonomyEffective decision making abilities under complex situationsKnow -how when to escalate Quality issues.InteractionTo 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.InnovationSelf starterDisseminating best practices, lessons learned, and successful quality improvement initiativesExploration and implementation of new approachesWillingness to experiment with new ideas and methodologies, while carefully considering potential risks and benefits to drive continuous improvementComplexity.Imported Takeda products, Manage networking of suppliersWhat 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 necessaryGood sense of urgency and strong follow up Scientific KnowledgeTravel 25 to 35% to a local warehouse within GurgaonLocationsIND - GurgaonWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
