Dr. Reddy's - Associate - Quality Control

Description:

- Analysis of the campaigns , investigations, and related analyses with trouble shooting

- Execution of the Analytical method validation as per the protocol

- Preparations of equivalency reports, transfer protocols & reports, investigation protocols & reports etc.

- Maintenance of lab compliance such as calibration schedules etc, preparation of SOPs and other documents.

- Coordination with CFTs e.g QC for analysis requirements, QA for document authorization and RA for filing requirements.

- Evaluate and use orthogonal approaches to resolve a problem and investigate the cause.

- Designing , Planning and execution of analytical activities

- Review analytical data generated on different analytical techniques for completeness and adequacy

- Analysis of results and discussion with the formulation team during the product development until the filing.

- Interaction with RA for filing requirements. Providing required data to regulatory and quality of respective plants in support of executing the project at plant and filing.

- Coordination with SCM & FR&D planning for analysis. Analyzing the results, documenting the observations and results and preparing the report.

- Respond to regulatory deficiencies on time.

- Identify the training needs of the team & implement effective training calendar for all the team members.

- Actively participate and resolve OOT/OOS observed at plants during stability analysis.

- Good data analytical skills with creative thinking ability.

- Guide the team in designing experiments on appropriate analytical techniques which are suitable and adequate for product development

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