Job highlights

- Responsible for review of Batch Manufacturing and Batch Packing records .
- Responsible for preparation of batch release certificate and ensuring batch release process performed as per the SOP
- Experience in review of analytical data generated through HPLC,GC,UV,IR,Dissolution,etc
- Responsible for review of stability protocol & report.
- Responsible for Preparation of Annual Product Quality Review.
- Responsible for review of Master Packing Card & Master Formula Card.
- Responsible for preparation and review of Process validation Protocols and reports.
- Responsible for review of Batch Manufacturing and Batch Packing records
- Responsible for preparation of batch release certificate and ensuring batch release process performed as per the SOP.
- Responsible for issuance of Formats, Logbooks, Register, protocol, reports,



BMRs and BPRs as per respective procedure.
- Responsible for review of QC documents such as Specifications and Standard Testing Procedure (RM, bulk, finished product, RST).
- Responsible for review of COAs (Raw Material, Packing Material & Finished Product).

Key Skills & Competencies:

- Sound knowledge of cGMP, GLP, and data integrity principles.
- Experience in review of analytical data generated through HPLC, GC, UV, IR, Dissolution, etc.
- Positive understanding of analytical method validation and transfer.
- Proficient in documentation and good communication skills.
- Familiar with regulatory expectations (USFDA, MHRA, WHO, etc.).

📌 Quality Assurance(AQA) (Hyderabad)
🏢 Promea Therapeutics
📍 Hyderabad