Quality Analyst

4 days ago

Pithampur, Madhya Pradesh, India JIAAN BIOTECH Full time ₹ 2,20,152 - ₹ 22,01,528 per year

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, ₹22,152.98 per month

Benefits:

  • Health insurance
  • Paid sick time
  • Provident Fund

Work Location: In person

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