Sr Research Associate, Technical Services

Par Health; Pudupakkam; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Par Health in Pudupakkam, India seeks a Senior Technical Services associate to support technology transfer activities, documentation, filing support and related tasks as part of lifecycle management.

The role emphasizes coordinating submissions, site transfers, validation, and ensuring cGMP compliance while collaborating with cross-functional teams to meet project timelines.

Qualifications

• Experience in technology transfer activities including submission, site transfer, validation, and lifecycle management.
• Strong documentation skills and process optimization.
• Experience supporting regulatory filings and quality systems.

Responsibilities

• Coordinate technology transfer submissions and site transfers.
• Prepare and finalize documents and processes for execution at site.
• Align team members and cross-functional teams to meet timelines.

Skills

Technology transfer coordination

Documentation

Regulatory filings

Quality systems

Cross-functional teamwork

Job description

India - Pudupakkam

Full time

R003299

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:

• 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.

Come join us! At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With a global workforce, we lead with pride and purpose- prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.