Qc Associate

1 week ago

Hyderabad, India Dr.Reddy's Full time

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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