Quality Assurance Manager

Role Objective

To establish and lead the Quality Assurance, Analytical Quality Control and Process Validation systems for our newly established Citrus Pectin manufacturing plant, ensuring consistent product quality, validated processes, robust documentation and compliance with applicable quality and safety standards.

Key Responsibilities

1. Quality Management System

• Establish and implement the Quality Management System (QMS), SOPs, work instructions and document control systems.
• Manage deviations, root-cause analysis, CAPA, change control, risk assessments and internal/customer audits.
• Ensure complete traceability, data integrity and batch documentation.

2. Equipment Qualification & Calibration

• Lead equipment qualification, including DQ/IQ/OQ/PQ, as applicable.
• Establish equipment and instrument qualification, calibration, verification and maintenance documentation.
• Ensure all critical equipment and measuring instruments remain in qualified and calibrated status.

3. Process Qualification & Validation

• Develop and execute process qualification and validation protocols for the pectin manufacturing process.
• Understand critical process parameters, including extraction, pH, temperature, filtration, precipitation, solvent recovery and drying.
• Establish in-process controls, sampling plans, acceptance criteria and revalidation requirements.
• Monitor process performance and investigate deviations and quality inconsistencies.

4. Analytical Quality Control

• Establish analytical methods, testing procedures and specifications for raw materials, intermediates and finished products.
• Ensure appropriate testing, method validation/verification, laboratory documentation and instrument calibration.
• Review analytical results and manage out-of-specification (OOS) and out-of-trend (OOT) investigations.
• Ensure compliance with relevant product parameters, including pectin content, degree of esterification, moisture, ash, pH, viscosity and gel strength, as applicable.

5. Finished Goods Approval & Documentation

• Review batch manufacturing records and analytical results before final product disposition.
• Prepare/review and approve Certificates of Analysis (COAs), product specifications, Safety Data Sheets (SDS/MSDS) and customer quality documentation.
• Establish batch traceability, quarantine and release procedures.
• Exercise independent authority to approve, hold, reject or release finished goods against approved specifications.

6. Safety & Risk Assessment

• Participate in process risk assessments and safety reviews, particularly for acid/alkali handling, IPA storage and recovery, and high-temperature operations.
• Coordinate with Engineering and EHS teams to ensure critical safety risks are assessed and corrective actions are implemented.

7. Cross-Functional Coordination & Continuous Improvement

• Work closely with Production, Engineering, Maintenance, R&D and Supply Chain teams to resolve process and quality issues.
• Track quality trends, reduce rejections and customer complaints, and drive continuous improvement.
• Support applicable quality certifications, customer audits and regulatory compliance requirements.

Candidate Profile

• Minimum 5 years of relevant experience in QA, QC, process validation or quality systems in pharmaceutical, specialty chemical, food ingredient, nutraceutical or similar process industries.
• Strong hands-on experience in equipment qualification, process validation, calibration, analytical methods and quality documentation.
• Good understanding of manufacturing processes, quality risk assessment, deviation management and CAPA.
• Experience in commissioning or establishing quality systems for a new manufacturing plant will be an advantage.
• Strong analytical, documentation, problem-solving and communication skills.

Job Location

• Nanded