QMS & Compliance Engineer

Job Description:

• Project Responsibilities
• Learn and understand Quality systems (QMS) and regulatory aspects applicable at the site to formulate Engineering Quality Plans for Qualification/Requalification, Validation, Scheduled Maintenance, and Reliability Plans for core engineering segments like Utilities, Process Maintenance, and Instrumentation.
• Develop and coordinate protocols and reports for Qualification/Requalification in collaboration with field engineering and QA teams to ensure timely handover of equipment and systems.
• Perform data collection and trend analysis to identify bottlenecks in the qualification process, including aspects like Mechanical Completion (MC), Pre-Startup Safety Review (PSSR), and Design vs Actual deficiencies (traceability Matrix).
• Collaborate with end-users to prepare Standard Operating Procedures (SOPs) for new equipment and systems.
• Create and maintain essential planning documents such as Calibration Planners, Instrument Criticality Assessments, Preventive Maintenance Planners, Validation Master Plans (VMP), and Computer System Validation (CSV) Planners.
• Assign and maintain records for asset codes, equipment IDs, and instrument IDs to ensure seamless documentation.
• Verify as-built drawings and prepare them to maintain compliance and records.
• Operational Responsibilities
• Support operations throughout the Maintenance lifecycle and processes for defined strategies of Maintenance.
• Handle process deviations, non-conformances, reworks, Corrective and Preventive Actions (CAPA), design changes, complaints, scrap, and changes tracking.
• Maintain and track SOP reviews and ensure systematic updates in operational systems.
• Prepare and keep records of Equipment/System master files, history cards, change tracking logs, and design development to ensure compliance.
• Serve as the department’s training coordinator (LMS) , ensuring compliance in training activities.
• Conduct process and GMP audits to ensure area compliance and high standards.
• Maintain statutory compliance planners with periodic reviews for alignment with legal and regulatory requirements.
• Lead initiatives for Quality Assurance (QA) and drive continuous improvement projects to enhance efficiency and reliability.
• Support engineering projects by preparing conceptual drawings and developing designs aligned with regulatory and operational standards.

Compile and maintain Engineering Operational Expenses (OPEX) data for monthly and quarterly reviews, identifying cost-saving opportunities.

Qualification: Bachelor’s degree in engineering

Experience: Minimum 7-8 years

Location: