Evaluation and execution of Submission,validation and trouble shooting activities.

Coordination and communications with CFT.

Protocols preparation and report evaluation and closure.

Co-ordination, Communication for the Technology Transfer of Submission, Site transfer, Validation and lifecycle management. Evaluation, preparation, optimization and finalizing the documents & process and successful implementation at site level. Aligning the team members and CFT’s to achieve organizational goals through discussion to meet the timelines. Participating in updating the project details in daily, weekly and monthly meetings. Risk evaluation and gap analysis of projects & finalizing the batch sizes to initiate the procurement of prerequisites before commencement of project at site. Preparation, review and approval of engineering, submission and validation batch documents and preparation and participation of gate meeting and/or project discussions. Monitoring of engineering, submission and validation batches as per the timelines and market requirement. Preparation of placebo and submitting the same to QC for testing as per project requirement. Support for regulatory filings for the required documentation. Handling of investigations to make quality documentation and to suggest the way forward. Handling of CMC queries to get the product approval on time and to make readiness for on time launch. Commercial support throughout the product lifecycle management.

Different Endo Initiatives:

Audit compliance. Ensuring cGMP at site level. Risk evaluation for Nitrosamine impurities.

Following and implementing the endo values during day-to-day activities.

Awareness of EHS policy, significant environment aspect & impacts associated with workplace and Contribution to environment management system. Supporting to the Cross functional team during Audit and Performing Internal Audits (Qualified Auditor). Responsible to follow and ensure the procedures pertaining to the environmental management system. Responsible to keep the workplace neat and clean.

Be the change you wish to see. Come join us! We want the best and brightest people at Endo to help us achieve our mission to develop life-enhancing products through focused execution. Our 3,000+ global team members are united by the important role that we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.