PurposeTo support Lab (Analytical) for maintaining Quality and compliance as per the GMP norms
Position / Job TitleQA Officer
DepartmentQuality Assurance Laboratory Quality Assurance
Reporting ToSection Head- Laboratory QualityAssurance
LocationSatara
Years of Experience6 Years
Dosage Form
Liquid formulation experience is essential, other formulation experience will be
considered addedadvantage
Job Responsibilities
/ Deliverables
Rubicon Research is a specialty pharmaceutical company focused on developing high quality products usinginnovative technologies for the globalmarket. We are committed to designing effective value-added formulations that enrich lives around the world.
Quality is an integral part of RubiconResearch's business principles.
From research and development to the manufacturing of our products, safety and quality are our first considerations.
Our Quality Systems, made up of policies, guidelines to ensure consistent product quality worldwide
At Rubicon, teamwork, engagement, ownership, and support by everyone are vital for achieving our quality objectives.
Requirements For The JOB
- Well versed in the analytical review of documents, which includes of those from GLP section,
- OOS, OOT, Events,Change control, CAPA related QMS handling
- Column management, Standard handling, glassware management, chemical management
- Retention samples management and review of stability sample and study management. To review of stability protocol/summary sheet
- Computer system validation, calibration & qualification of instruments. Review of audit trail from the computerized systems.
- Ensure QC laboratory compliance at all times, participate in Lab checkrounds.
- Preparation & review of OOS/OOT/Events trending.
- Review of analytical documents, chromatograms related to AMT/AMV protocols and reports.
- Preparation of SOPs
- To reviewthe Analytical reportsin support of Batch releaseactivities
