QA- AQA ( Analytical Quality Assurance ) - API - Dahej

Troikaa Pharmaceuticals; Dahej; On-site; INR 400,000 - 650,000; Full time

Job summary

Troikaa Pharmaceuticals is seeking a QA Reviewer to ensure data integrity and compliance across stability, finished product, RM/PM, water and EM records. The role involves detailed review of electronic datasets, calibration status, and adherence to specifications per MOA or SOPs.

Responsibilities include preparing and reviewing stability summaries and QC instrument validation documents; assessing OOS/OOT and lab deviation investigations to maintain quality standards.

Qualifications

• Experience with GMP/QA documentation review.
• Familiarity with URS, IQ, OQ, PQ concepts.

Responsibilities

• Review electronic data for finished product, stability samples, and related materials as per checklist.
• Prepare and review stability summary reports.
• Review URS, DQ, IQ, OQ, PQ documents of QC instruments.
• Review OOS/OOT, lab deviation and lab incident reports.

Skills

QA documentation

GxP knowledge

Stability testing

Instrument calibration

Education

Bachelor's degree in Pharmacy

Master's degree in Pharmacy

Tools

QC instruments

Calibration records

Job description

Review of electronic data for Finished product, stability samples, AMV, RM, PM, water and EM as per review checklist, raw data, worksheet, working standards/reference standards details, instruments calibration status, acceptance criteria as per specification and MOA verify and update observations.

Prepared and Review of stability summary reports.

Review of URS, DQ, IQ, OQ, PQ documents of QC instruments.

To review of OOS, OOT, lab deviation and lab incident investigation reports.