AQA Reviewer

Emcure; Pune District; On-site; INR 540,000 - 660,000; Full time

Job summary

Emcure in Pune seeks a QA/QC professional with strong experience in reviewing analytical data for raw materials and finished drug products (oral solids). You will evaluate process validation data, analytical method validation/verification/transfer protocols, and stability trend analyses to ensure compliance with CGMP and ICH guidelines.

You should be proficient in SAP and analytical software such as Empower and Chromeleon, and able to handle OOS/OOT/OOC deviations, instrument qualification, CSV,

Qualifications

• Experience in reviewing analytical data for raw materials and finished drug products (oral solids).
• Review/evaluate process validation data, analytical method validation/verification/transfer protocols.
• Review stability study trends and data.
• Proficiency with SAP and instrumental software Empower/Chromeleon.
• Review qualification, CSV and calibration documents for laboratory instruments.
• Handling OOS/OOT/OOC and laboratory deviations/incidences.
• Knowledge of CGMP, ICH and other regulatory guidelines.
• Proficient in English (written and verbal).

Skills

Analytical data review

Process validation review

Stability data analysis

OOS/OOT/OOC handling

Regulatory knowledge CGMP/ICH

English proficiency

Tools

SAP

Empower

Chromeleon

Job description

• 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).