Role & respons

QA Roles and Responsibilities
Ensure compliance with cGMP, WHO-GMP, ICH, and SOPs.
Review and approve Batch Manufacturing Records (BMR) and Batch Packing Records (BPR).
Prepare, review, revise, and control Standard Operating Procedures (SOPs).
Perform line clearance before production and packaging activities.
Conduct in-process quality checks during manufacturing.
Handle deviations, incidents, change controls, and CAPA (Corrective and Preventive Actions).
Review and approve analytical reports, logbooks, and quality records.
Participate in internal audits, regulatory inspections, and customer audits.
Monitor calibration and validation activities for equipment and processes.
Review cleaning validation and process validation documents.




Issue and control documents using Valuable Documentation Practices (GDP).
Investigate Out of Specification (OOS) and Out of Trend (OOT) results with QC.
Monitor environmental and housekeeping compliance in production areas.
Train employees on GMP, SOPs, data integrity, and quality systems.
Ensure products are released only after meeting all quality requirements.

Skills Required
Knowledge of cGMP, GLP, GDP, and ICH guidelines.
Familiarity with deviation, CAPA, change control, OOS/OOT, and validation.
Robust documentation and communication skills.
Attention to detail and problem-solving ability.ibilities

Preferred candidate profile

📌 Quality Assurance Telangana
🏢 The Pharma Patashala
📍 Telangana