AQA Reviewer
Emcure Pharmaceuticals · Pune · onsite · Posted 62d ago
Undisclosed4–5 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
- Experience in review of analytical data w.r.t. raw material and Finished drug products (Oral solids).
- Experience in review and evaluation of process validation data , Analytical Method Validation/verification/ transfer protocol, reports and data.
- Experience in review and evaluation of stability study trends.
- Should have sufficient skills and handling experience for SAP , instrumental softwares (Empower, Chromeleon),
- Experience in review of analytical data w.r.t Qualification, CSV and Calibration related documents for laboratory instruments.
- Experience of handling/documentation related to OOS, OOT, OOC, Deviations and Laboratory events /incidences.
- Should have sufficient knowledge of CGMP,ICH guidances& other regulatory guidances. Should be aware with regulatory requirements and updates.
- Should be proficient in English ( preferably writing with grammatical awareness).
Sourced from naukri
Skills
ICH guidancesOOCootoosAnalytical data reviewAMVFDP
About Emcure Pharmaceuticals
Emcure Pharmaceuticals
Pharma
6.7k+
employees
1983
43 years old
Pune, Maharashtra
India
₹6.7L PA avg
Avg at Emcure Pharmaceuticals
About
Emcure Pharmaceuticals is driven by the purpose to develop, manufacture and market a broad range of pharmaceutical products globally.
Industries
PharmaMedia & Entertainment / Publishing
Employee ratings
10 reviews
3.7/ 5
Culture
3.0
Career growth
2.6
Work-life
2.6
Employees rate it well for
Overall Company37Compensation & Benefits35
Find them on