Quality Assurance(AQA)

Promea Therapeutics Pvt. Ltd.; Hyderabad; On-site; INR 400,000 - 600,000; Full time

Job summary

Promea Therapeutics Pvt. Ltd. Hyderabad invites walk-in interviews for Analytical Quality Assurance. The role focuses on reviewing stability data, regulatory documentation, QC records, and batch release processes to ensure GMP compliance and data integrity.

The incumbent will handle preparation and review of quality-related documents, participate in method validation activities, and communicate findings with cross-functional teams in a fast-paced pharmaceutical environment.

Responsibilities

• Review stability protocol and reports.
• Prepare and review Annual Product Quality Review.
• Review Master Packing Card and Master Formula Card.
• Prepare and review Process validation Protocols and reports.
• Review Batch Manufacturing and Batch Packing records.
• Prepare batch release certificates and ensure batch release per SOP.
• Issue formats, logbooks, registers, protocols, reports, BMRs and BPRs as per procedures.
• Review QC documents such as Specifications and Standard Testing Procedures (RM, bulk, finished product, RST).
• Review COAs (Raw Material, Packing Material & Finished Product).
• Maintain sound knowledge of cGMP, GLP, and data integrity principles.
• Experience in review of analytical data via HPLC, GC, UV, IR, Dissolution, etc.
• Understand analytical method validation and transfer.
• Proficient in documentation and good communication skills.
• Familiar with regulatory expectations (USFDA, MHRA, WHO).

Job description

Walk-in interviews for Analytical Quality Assurance (AQA)

Job Description

Key Responsibilities:

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