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

- Valuable 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.

📌 QA Executive (Bengaluru)
🏢 Melting Pot Concepts
📍 Bengaluru