Sr Research Associate, Technical Services

Endo Pharmaceuticals; India; On-site; INR 900,000 - 1,200,000; Full time

Job summary

Endo Pharmaceuticals seeks a Senior Technical Services associate to manage technology transfer activities, documentation, filing support and related responsibilities. The role focuses on coordinating submissions, site transfers, validation and lifecycle management, while ensuring cGMP compliance and timely project execution across sites.

Responsibilities include risk evaluation, batch size decisions, review of batch documents, gate meetings, and regulatory filings.

Responsibilities

• Co-ordination, Communication and Smooth Execution for Technology Transfer Activities.
• Evaluation, preparation, optimization and finalizing the documents & process for successful execution and implementation at site.
• Aligning team members and cross-functional teams to meet timelines.
• Participation in updating project details in daily, weekly and monthly meetings.
• Risk evaluation and gap analysis of projects & finalizing batch sizes to initiate procurement before commencement at site.
• Preparation, review and approval of engineering, submission and validation batch documents and participation in gate meetings and project discussions.
• Monitoring of engineering, submission and validation batches as per timelines and market requirements.
• Preparation of placebo and submission to QC for testing as per project requirement.
• Support for regulatory filings for required documentation.
• Handling investigations to improve quality documentation and propose next steps.
• Handling CMC queries to secure product approval on time and readiness for launch.
• Commercial support throughout product lifecycle management.
• Audit compliance; ensuring cGMP at site; risk evaluation for nitrosamine impurities; adherence to organizational values.

Job description

Job Description Summary

Senior Technical Services associate for handling of technology transfer activities of execution, documentation, filing support and other activities as responsible.

Job Description

Primary Responsibilities:

Co-ordination, Communication and Smooth Execution for Technology Transfer Activities:

• a) Co-ordination, Communication for the Technology Transfer of Submission,Site transfer, Validation and lifecycle management of products.
• b) Evaluation, preparation, optimization and finalizing the documents & process forsuccessful execution and implementation at site.
• c) Aligning the team members and CFT's to achieve organizational goals throughdiscussion to meet the timelines.
• d) Participating in updating the project details in daily, weekly and monthly meetings.
• e) Risk evaluation and gap analysis of projects & finalizing the batch sizes to initiate theprocurement of prerequisites before commencement of project at site.
• f) Preparation, review and approval of engineering, submission and validation batchdocuments and preparation and participating in gate meeting and project discussions.
• g) Monitoring of engineering, submission and validation batches as per the timelinesand market requirement.
• h) Preparation of placebo and submitting the same to QC for testing as per projectrequirement.
• i) Support for regulatory filings for the required documentation.
• j) Handling of investigations to make quality documentation and to suggest the wayforward .
• k) Handling of CMC queries to get the product approval on time and to make readinessfor on time launch.
• l) Commercial support throughout the product lifecycle management.

Other Activities.

• a) Audit compliance.
• b) Ensuring cGMP at site level.
• c) Risk evaluation for Nitrosamine impurities.
• d) Following and implementing the organization values during day-to-day activities.

Secondary Responsibilities:

• a) Awareness of EHS policy, significant environment aspect & impacts associated with workplace and contribution to environment management system.
• b)Supporting to the cross functional team during Audit and performing internal Audits (Qualified auditor).
• c)Responsible to follow and ensure the procedures pertaining to the environmental management system.
• d)Responsible to keep the workplace neat and clean.