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
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