Job Description Summary
Evaluation and execution of Submission,validation and trouble shooting activities.
Coordination and communications with CFT.
Protocols preparation and report evaluation and closure.
Job Description
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.
Commitment to Diversity, Equity, and Inclusion:
At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person’s unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.
Top Skills
What We Do
At Endo, our far-reaching vision is simple: to help everyone we serve live their best life. As a specialty pharmaceutical company, we’re motivated by a strong sense of purpose to find better ways to meet unique medical needs.
Our global team of passionate employees understands the importance of their work. We’re dedicated to supporting one another as we connect with communities and foster partnerships that elevate quality-of-life and bring the best treatments forward.
Our uncompromising commitment results in the delivery of life-enhancing therapies. From intelligent product selection to commercialization, we strive to make a meaningful, tangible impact to help everyone live their best life.
Endo has global headquarters in Malvern, Pennsylvania.
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