Sr. Executive-AQA
Job Description
Sr. No.
Responsibilities
1.0
Documents review and approved
1.1
Finished product:- Approved COA, electronic data review checklist, raw data, worksheet, working standards/reference standards details, instruments calibration status, acceptance criteria as per specification and MOA verify and update observations.
1.2
In-process samples: - Approved results, electronic data review checklist, raw data, worksheet, working standards/reference standards
details, instruments calibration status, acceptance criteria as per specification and MOA verify and update observations.
1.3
Stability samples:- Approved COA, electronic data review checklist, raw data, worksheet, working standards/reference standards details, instruments calibration status, acceptance criteria as per specification and MOA verify and update observations.
1.4
Microbiological reports, Trending documents review.
1.5
Review and approve stability summary reports.
2.0
Review of instruments audit trails on monthly basis.
2.1
Lab solution CS software (HPLC, GC, IR, UV)
2.2
Tiamo 2.5 software (Auto Titrator, KF Titrator)
2.3
Spectra Manager-II (Polarimeter)
2.4
TOC-Control L (TOC analyzer)
2.5
Micro-laboratory instruments
2.6
ICDAS (Stability chambers)
3.0
Validation/Qualification protocol and report review and approved with raw data.
3.1
Analytical Method validation protocols and reports.
3.2
In-process validation protocol and reports.
3.3
Analytical Method transfer protocol and reports.
3.4
Cleaning method validation protocol and reports.
3.5
Analyst qualification protocol and reports.
3.6
Instruments qualification/re-qualification protocol and reports.
3.7
Stability study protocol and reports.
3.8
Review and approve of URS, DQ, IQ, OQ, PQ documents of QC instruments.
4.0
To review OOS, OOT, lab deviation and lab incident investigation reports.
5.0
Fortnightly AQA compliance audit at QC lab as per AQA SOP.
6.0
Stability sample management
6.1
To prepare and review stability protocols and stability study report.
6.2
Responsible for operation and cleaning of stability chambers as per SOP.
6.3
To maintain stability area activity.
6.4
Responsible for stability sample management as per SOP.