QA Executive

Role & responsibilities

1. Quality Assurance & GMP Compliance

• Monitor manufacturing activities to ensure compliance with approved SOPs, GMP/GHP and quality procedures.
• Ensure adherence to approved manufacturing processes and specifications.
• Conduct routine checks of production and packing areas.
• Verify line clearance before commencement of manufacturing and packing activities.
• Ensure proper hygiene and housekeeping practices are followed in production areas.

2. Batch Documentation

• Review Batch Manufacturing Records (BMR) and Batch Packing Records (BPR) for completeness and accuracy.
• Verify production entries, process parameters, yields, reconciliation and other critical information.
• Ensure proper documentation and traceability of manufacturing activities.
• Review and maintain QA-related records and reports.

3. In-Process Quality Assurance

• Perform in-process checks at various stages of manufacturing and packing.
• Monitor critical process parameters and ensure they remain within approved limits.
• Identify deviations or abnormalities and escalate them to the QA Manager.
• Coordinate with Production and QC for resolution of quality-related issues.

4. Deviation, CAPA & Change Control

• Initiate and support investigation of deviations, incidents and non-conformances.
• Assist in root-cause analysis and preparation of CAPA.
• Support implementation and monitoring of corrective and preventive actions.
• Assist in change-control activities and assess potential quality impact.

5. Raw Material & Finished Product Release

• Review QC test reports and relevant documentation before release of raw materials and finished products.
• Ensure materials/products meet approved specifications before release.
• Coordinate with QC, Production and Warehouse teams for status and release activities.
• Ensure proper handling of rejected, quarantined and approved materials.

6. SOP & Documentation Management

• Assist in preparation, review and implementation of SOPs, work instructions, formats and quality documents.
• Ensure current approved versions of documents are available at the relevant locations.
• Maintain controlled copies and quality records.
• Support document revision and periodic review activities.

7. Audit & Inspection Support

• Support internal, customer and regulatory audits.
• Ensure manufacturing and quality records are readily available during audits.
• Track audit observations and coordinate with concerned departments for CAPA closure.
• Support maintenance of audit readiness.

8. Validation & Qualification

• Support validation and qualification activities related to processes, cleaning,equipment and testing procedures, as applicable.
• Assist in preparation and execution of validation protocols and reports.
• Ensure validation records are properly documented and maintained. FSSAI's nutraceutical guidance identifies validation of processing, testing and cleaning procedures as part of GMP-related validation activities. (FSSAI)

9. Complaint & Recall Support

• Assist in investigation of customer/product complaints.
• Coordinate with QC, Production and other departments for root-cause investigation.
• Support product recall/mock recall activities and maintain relevant records.
• Ensure traceability of batches and distribution records where required.(FSSAI)

Required Skills

• Good knowledge of GMP, SOPs and Quality Assurance practices.
• Understanding of nutraceutical/food supplement manufacturing processes.
• Knowledge of BMR/BPR review and batch documentation.
• Knowledge of deviation, CAPA, change control and root-cause analysis.
• Understanding of GLP/GDP and documentation practices.
• Good knowledge of QA/QC processes and coordination.
• Good analytical and problem-solving skills.
• Strong attention to detail.
• Good written and verbal communication skills.
• Working knowledge of MS Excel and MS Office.

Qualification

• B. Pharm / M. Pharm from a recognized university.
• Candidates with experience in nutraceutical, pharmaceutical, food supplement or FMCG manufacturing will be preferred.

Experience

24 years of relevant experience in Quality Assurance, preferably in a manufacturing environment.

Key Performance Indicators (KPIs)

• Batch record review accuracy and timeliness
• GMP/SOP compliance
• Timely closure of deviations and CAPA
• Reduction in recurring quality deviations
• Audit readiness and timely closure of audit observations
• Documentation compliance
• Timely product/material release coordination
• Compliance with hygiene and in-process quality requirements

Ideal Candidate

The ideal candidate should be hands-on, detail-oriented and comfortable working on the manufacturing floor, with a strong understanding of QA documentation, GMP and quality systems.