Designation: QA Officer
Reporting To: Assistant Manager / Manager – QA
Industry: Pharmaceutical / API Manufacturing
Experience: 2–5 Years
Employment Type: Full-Time
Location: Turbhe

1. Job Purpose

To perform day-to-day Quality Assurance activities and ensure that manufacturing, documentation, testing, and other operational activities comply with GMP requirements, approved SOPs, specifications, regulatory requirements, and company quality standards.

2. Key Responsibilities A. Shop-Floor QA & GMP Compliance

• Monitor manufacturing and packing activities to ensure compliance with approved SOPs and GMP requirements.
• Perform routine shop-floor inspections and verify compliance with GMP practices.
• Check line clearance before commencement of manufacturing/packing activities.
• Monitor critical process parameters and in-process activities.
• Verify equipment status, area cleanliness, environmental conditions, and material status.
• Report and escalate GMP deviations and quality issues to the QA supervisor/manager.

B. Batch Documentation

• Review BMRs, BPRs, logbooks, checklists, and other manufacturing documents for completeness and accuracy.
• Ensure entries are made as per Good Documentation Practices (GDP).
• Verify corrections, signatures, dates, and traceability of records.
• Identify documentation discrepancies and coordinate with concerned departments for correction.

C. Quality Management System

• Support handling of deviations, CAPA, change controls, OOS/OOT, complaints, and other quality events.
• Assist in investigation and root-cause analysis.
• Track assigned CAPA and change-control activities.
• Maintain QA records and quality documentation.
• Support implementation and monitoring of QMS procedures.

D. Sampling & Material/Finished Product Activities

• Perform or coordinate sampling of raw materials, packaging materials, intermediates, and finished products as per approved procedures.
• Verify material status labels and storage conditions.
• Coordinate with QC for sample submission and testing.
• Ensure proper status identification of materials and products.

E. Document Control

• Issue and control SOPs, formats, logbooks, and other controlled documents.
• Ensure obsolete documents are withdrawn from use.
• Maintain controlled-copy records as applicable.
• Support periodic review and revision of QA documents.

F. Audit & Inspection Support

• Support preparation for internal audits, customer audits, and regulatory inspections.
• Participate in GMP audits and inspections.
• Provide required QA documentation and records during audits.
• Assist in tracking and closing audit observations.

G. Training

• Participate in GMP, SOP, GDP, data integrity, and other quality-related training.
• Support training of production and QA personnel on applicable SOPs.
• Maintain training records and ensure completion within defined timelines.

H. Validation & Qualification Support

• Assist QA in review and execution of validation and qualification activities.
• Support review of protocols and reports related to equipment qualification, process validation, cleaning validation, and other validation activities.
• Ensure activities are performed according to approved protocols.

3. Daily QA Activities

• Perform manufacturing area/shop-floor checks.
• Verify line clearance.
• Review manufacturing documentation.
• Check equipment and area status.
• Monitor GMP compliance.
• Verify material/product status.
• Record and report deviations.
• Coordinate with Production and QC on quality-related issues.
• Ensure proper documentation and data integrity.

4. Key Performance Indicators (KPIs)

• Timely completion of batch record review.
• Compliance with GMP and GDP requirements.
• Timely reporting and documentation of deviations.
• Timely completion of assigned CAPA/change controls.
• Accuracy of QA documentation.
• Audit and inspection readiness.
• Training compliance.
• Reduction in documentation errors and recurring GMP observations.

5. Educational Qualification

Essential:

• B.Pharm / M.Pharm / B.Sc. / M.Sc. in Chemistry, Life Sciences, or a related field.

6. Experience

• 2–5 years of relevant experience in Quality Assurance, preferably in pharmaceutical/API manufacturing.
• Experience in GMP documentation, shop-floor QA, batch record review, deviations, CAPA, and change control will be preferred.

7. Technical Knowledge

• Basic to good knowledge of cGMP and GDP.
• Understanding of pharmaceutical/API manufacturing processes.
• Knowledge of:
• BMR/BPR review
• Line clearance
• Shop-floor QA
• Deviations
• CAPA
• Change Control
• OOS/OOT
• Data Integrity
• Document Control
• GMP Audits
• Basic knowledge of validation and qualification activities.

8. Required Competencies

• Attention to detail
• Good documentation