Sr Research Associate, Technical Services

Endo Pharmaceuticals; Chennai District; On-site; INR 900,000 - 1,400,000; Full time

Job summary

Endo Pharmaceuticals in Chennai is seeking a Senior Technical Services associate to oversee technology transfer activities, documentation, submission support, and related tasks.

Responsibilities include coordinating technology transfer submissions and site transfers, validating and lifecycle managing products, ensuring cGMP compliance, supporting regulatory filings, and aligning cross-functional teams to meet project timelines. The role requires strong communication and documentation skills.

Qualifications

• Experience in technology transfer activities including submission, site transfer, validation and lifecycle management.
• Ability to coordinate and communicate to align team members and cross-functional teams to meet timelines.
• Experience with audits and ensuring cGMP at site.

Responsibilities

• Co-ordination, Communication and Smooth Execution for Technology Transfer Activities: submission, site transfer, validation and lifecycle management.
• Evaluation, preparation, optimization and finalizing the documents process for successful execution and implementation at site.
• Aligning the team members and CFTs to achieve organizational goals through discussion to meet timelines.

Skills

Co-ordination

Communication

Technology transfer

Documentation

Regulatory filings

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 for
  successful execution and implementation at site.
• c) Aligning the team members and CFT s to achieve organizational goals through
  discussion 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 the
  procurement of prerequisites before commencement of project at site.
• f) Preparation, review and approval of engineering, submission and validation batch
  documents and preparation and participating in gate meeting and project discussions.
• g) Monitoring of engineering, submission and validation batches as per the timelines
  and market requirement.
• h) Preparation of placebo and submitting the same to QC for testing as per project
  requirement.
• i) Support for regulatory filings for the required documentation.
• j) Handling of investigations to make quality documentation and to suggest the way
  forward .
• k) Handling of CMC queries to get the product approval on time and to make readiness
  for 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.