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17 Endo Pharmaceuticals Jobs
Sr Research Associate, Technical Servicesc
3-6 years
Kolkata, Mumbai, New Delhi + 4 more
1 vacancy
Sr Research Associate, Technical Servicesc
Endo Pharmaceuticals
posted 11d ago
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Key skills for the job
Job Description
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
Employment Type: Full Time, Permanent
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