Sr Executive, Lab QA

Amneal Pharmaceuticals; Ahmedabad District; On-site; INR 700,000 - 1,100,000; Full time

Job summary

Amneal Pharmaceuticals in Ahmedabad seeks a QA reviewer to ensure data integrity of RM, PM, in-process, FP and stability samples. You will approve COAs, verify data in LIMS, and validate documentation against GLP and cGMP standards.

Responsibilities include reviewing SOPs, method transfer/validation data, instrument calibration records, CSV documents, and audit trails. Requires a B.Pharm; 5+ years in QA for analytical labs.

Qualifications

• Review analytical data and COAs across RM/PM/in-process/FP/stability samples.
• Verify compliance with GLP and cGMP through documentation review.
• Ensure ALCOA data integrity and audit trail reviews.

Responsibilities

• Review and approve COAs for RM/PM/in-process/FP and stability samples.
• Review SOPs, STPs, specifications, and lab documents.
• Verify data in LIMS and manual records for accuracy.
• Review method transfer/validation/verification data and related reports.
• Review instrument calibration/verification/qualification records.
• Review CSV documents and computer validation materials.
• Review audit trails for Empower and CDS systems.
• Review stability schedules and reports.
• Ensure compliance with GLP/cGMP and ALCOA principles.
• Review investigations relating to raw data (OOS/OOAL/OOT) and changes.
• Review vendor qualification and reduced testing reports.
• Review COAs from contract testing labs and reagent preparations.
• Verify analyst qualification data and approvals.
• Oversee overall documentation compliance in lab activities.

Skills

Data review

Quality assurance

GLP/cGMP

LIMS

COA review

Documentation

Education

B. Pharm

M. Pharm

Tools

LIMS

Empower

CDS systems

Job description

1. Review analytical data for Raw Materials (RM), Packaging Materials (PM), in-process samples, Finished Products (FP), stability samples, working standards, reference standards, and other test samples.
2. Review and approve Certificates of Analysis (COAs) for RM, PM, in-process samples, FP, stability working standards, reference standards, and other test samples. samples.
3. Review SOPs, STPs, specifications, and other laboratory documents.
4. Verify the accuracy of data entered in LIMS and manual documentation systems.
5. Review protocols and reports related to analytical method transfer, validation, verification, and waiver activities. Review analytical raw data associated with method transfer, validation, and verification studies.
6. Review and approve daily verification, calibration, and qualification records of laboratory instruments and equipment.
7. Review and approve Computer System Validation (CSV) documents.
8. Review instrument logbooks, calibration records, and third-party calibration reports.
9. Review and approve the audit trail reports for Empower and non-CDS systems.
10. Review stability schedules, stability protocols and stability reports.
11. Ensure data integrity and compliance with ALCOA principles and documentation practices. Verify analytical records for compliance with GLP and cGMP requirements.
12. Review investigations related raw data and report i.e. OOS, OOAL/OOT, deviations, incidents, and change controls.
13. Review vendor qualification reports and related documentation.
14. Review reduced testing reports and related documentation.
15. Review analytical data and COAs received from contract testing laboratories.
16. Review and approve preparation records of reagents, mobile phases, diluents, impurity solutions, and other laboratory solutions.
17. Review analytical raw data for analyst qualification and approved.
18. Verify compliance of laboratory activities through documentation review.

Additional Responsibilities

Education

• B. Pharm B. Pharm - Required

• M. Pharm M. Pharm - Preferred

Experience

• 5 years or more in 5 - 8 Years