QA Documentation - Gurgaon, India - Ls Hireman consulting Pvt Ltd
Description
Current JOB Responsibilities:
- Quality management system (QMS) and Documentation.
- Handling of Change control.
- Handling of Deviation.
- Handling of CAPA.
- Handling of OOS investigation and preparing trend analysis of OOS.
- Handling of Incidents and investigating CAPA to close incidents and Prepare
- Trend analysis of Incidents.
- Handling of OOT and involve investigating root cause and impact of OOT.
- Investigations & root cause analysis.
- Audit trails for analytical instruments in QC of software s e.g., Lab solution,
- LC solution, Open LAB, PAMAS-USP for TOC, Tiamo2.5 for Auto titrator,
- Advance expertViatek
- Reviewing & Preparation of Standard Testing Procedures.
- Reviewing & Preparation of Standard Operating Procedures.
- Review of Stability Protocols and summary sheet.
- Preparation & Review of DATA for Regulatory Department.
- VALIDATION / QUALIFICATIONS /CALIBRATIONS
- Stability study.
Qualification :
B.sc, M.sc, B. pharma, M.pharma.
- Process validation.
- Analytical Method Validation.
- Qualification of instruments.
- Calibration of instruments.
- Analyst validation.
- Instrument handling.
- Handling of HPLC Prominence
- I/Shimadzu.
- Handling of GC.
- Handling of UV.
- Handling of Auto titrator
Job Types:
Full-time, Regular / Permanent
Salary:
₹18, ₹22,000.00 per month
Ability to commute/relocate:
- Gurgaon, Haryana: Reliably commute or planning to relocate before starting work (required)
Education:
- Bachelor's (preferred)
Experience:
- total work: 3 years (preferred)
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