Rubicon Research is a specialty pharmaceutical company focused on developing high quality products using innovative technologies for the global market. We are committed to designing effective value-added formulations that enrich lives around the world.
Post : Senior Officer
Job Responsibilities / Deliverables
• Well versed in the analytical review of documents, which includes those from GLP section.
• Handling of OOS, OOT, Events, Change control and CAPA.
• Review and ensure compliance of Column management, Standard management, glassware management and chemical management.
• Responsible for Retention samples management and review of stability sample and stability study management. To review of stability protocol/summary sheet
• Review Computer system validation, calibration & qualification of instruments. Review of audit trails from the computerized systems.
• Ensure QC laboratory compliance at all times, participate in Lab check rounds.
• Preparation & review of OOS/OOT/Events trending.
• Review of analytical documents, chromatograms related to AMT/AMV protocols and reports.
• Preparation of SOPs
• To review the Analytical reports in support of Batch release activities
• To review and approve the batches with generation of Certificate of Analysis for Finished Product
• Review Analyst qualification data
Candidate Profile
• Should be Graduate/Post graduate in Science or Pharmacy
• Must have knowledge on handling HPLC, GC, KF, Dissolution. FTIR, FTNIR is preferable.
• Exposure to various regulatory bodies like US FDA, MHRA, TGA
• Exposure to specific dosage forms like OSD.
• Expertise in Qualification of CSV instrument documents verification
• Expertise in Method validation and Analytical method transfer process
• Exposure to expertise towards handling of QMS records
Role is expected to work in all shifts.
Expected to visit Satara/Thane sites at least twice a month on need basis.
Additional Information
Department - Quality Assurance – Analytical Lab Quality Assurance
Reporting To - Senior General Manager –Quality Assurance
Location - Pithampur
Years of Experience - 4 Years
Senior Officer : Apply here
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