Quality Analyst

Job Responsibilities – QA Officer

• Review and approve batch manufacturing records (BMRs) and batch packaging records (BPRs).
• Prepare, issue, and control SOPs, logbooks, and controlled documents.
• Ensure all documentation is maintained as per Good Documentation Practicesand ALCOA+principles.
• Handle deviations, CAPA, OOS/OOT investigations, and change controls.
• Maintain QMS documents and ensure timely closure of quality events.
• Support in product quality reviews (PQR/APQR).
• Perform line clearance before production and packaging activities.
• Monitor in-process checks to ensure compliance with approved procedures.
• Verify usage of approved raw materials and packaging materials.
• Participate in internal audits and prepare for regulatory/customer inspections (e.g., FDA, WHO).
• Ensure implementation of audit findings and compliance with cGMP.
• Prepare and conduct vendor qualification audits when required.
• Conduct or coordinate GMP and GDP training for employees.
• Monitor adherence to SOPs, GMP, and safety practices across departments.
• Maintain training records of personnel.
• Review and approve Certificates of Analysis (COA) and Certificates of Compliance.
• Ensure that only tested and released materials are used in production.
• Support batch disposition in coordination with QA Manager.
• Participate in qualification of equipment, utilities, and facilities (IQ/OQ/PQ).
• Support validation activities – process validation, cleaning validation, analytical method validation, etc.
• Contribute to quality risk assessments and mitigation activities.
• Suggest improvements in systems and processes to enhance compliance and efficiency.
• Monitor and ensure data integrity throughout all QA/QC processes

Job Types: Full-time, Permanent

Pay: ₹11,693.84 - ₹22,152.98 per month

Benefits:

• Health insurance
• Paid sick time
• Provident Fund

Work Location: In person

Speak with the employer
+91 8349999795