Jobs at Par Health

The Senior Research Associate, Technical Services is responsible for handling technology transfer activities including execution, documentation, filing support and other related activities.

The role involves coordination, communication and smooth execution of technology transfer activities for submission, site transfer, validation and lifecycle management of products. The position will support document preparation and review, project execution, risk evaluation, gap analysis, engineering, submission and validation batches, regulatory filings, CMC queries, investigations and commercial product lifecycle management.

• Technology Transfer and Project Execution
• Coordinate and communicate for technology transfer of submission, site transfer, validation and lifecycle management of products.
• Evaluate, prepare, optimize and finalize documents and processes for successful execution and implementation at site.
• Align team members and cross-functional teams to achieve organizational goals and meet project timelines.
• Participate in daily, weekly and monthly meetings to update project details.
• Perform risk evaluation and gap analysis of projects.
• Finalize batch sizes and initiate procurement of prerequisites before commencement of projects at site.
• Documentation and Validation
• Prepare, review and approve engineering, submission and validation batch documents.
• Prepare for and participate in gate meetings and project discussions.
• Monitor engineering, submission and validation batches as per timelines and market requirements.
• Prepare placebo and submit it to QC for testing as per project requirements.
• Regulatory and CMC Support
• Support regulatory filings with required documentation.
• Handle investigations to support quality documentation and suggest the way forward.
• Handle CMC queries to support timely product approval and readiness for on-time launch.
• Provide commercial support throughout the product lifecycle management.
• Quality and Compliance
• Support audit compliance.
• Ensure cGMP requirements at site level.
• Perform risk evaluation for Nitrosamine impurities.
• Follow and implement organizational values during day-to-day activities.
• Audit and Cross Functional Support
• Support cross-functional teams during audits.
• Perform internal audits as a qualified auditor.
• Coordinate with cross-functional teams to support project and audit requirements.
• EHS and Environmental Responsibilities
• Maintain awareness of EHS policy and significant environmental aspects and impacts associated with the workplace.
• Contribute to the environmental management system.
• Follow and ensure procedures pertaining to the environmental management system.
• Keep the workplace neat and clean.

• Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Life Sciences, Chemical Engineering or a related discipline.
• Experience in Technical Services, Technology Transfer, Pharmaceutical R&D or related functions.
• Knowledge of technology transfer activities including submission, site transfer, validation and lifecycle management.
• Experience in preparation, review and approval of engineering, submission and validation batch documents.
• Knowledge of cGMP and pharmaceutical quality requirements.
• Understanding of regulatory filings and CMC requirements.
• Experience with risk evaluation, gap analysis and project documentation.
• Knowledge of audit compliance and internal audit activities.
• Awareness of EHS and environmental management system requirements.