Summary

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

Primary Responsibilities

Co-ordination, Communication And Smooth Execution For Technology Transfer Activities

- Co-ordination, Communication for the Technology Transfer of Submission,

Site transfer, Validation and lifecycle management of products.
- Evaluation, preparation, optimization and finalizing the documents & process for

successful execution and implementation at site.
- 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 participating in gate meeting and 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.

Other Activities.
- Audit compliance.
- Ensuring cGMP at site level.
- Risk evaluation for Nitrosamine impurities.
- Following and implementing the organization values during day-to-day activities.

Secondary Responsibilities

- Awareness of EHS policy, significant setting 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.

📌 Sr Research Associate, Technical Services (Kanchipuram)
🏢 Par Health
📍 Kanchipuram