Senior Officer

Job Description Responsible for Quality Assurance oversight of engineering activities, including equipment qualification, utility systems, maintenance, calibration, and engineering change controls. Ensures all engineering systems operate in a validated and compliant state, maintaining product quality, data integrity, and regulatory compliance. Position / Job Title - Officer Department - Quality Assurance: In-Process Quality Assurance Engineering Reporting To - Sr. Manager, Quality Assurance Location - Pithampur Years of Experience - 4-7 Years Dosage Form - Solid Oral/ Cream/ Ointment Job Responsibilities / Deliverables - Engineering QA Oversight Provide QA Oversight For: Equipment (manufacturing and packing machines) Utility systems (HVAC, Purified Water, Compressed Air, BMS) Ensure engineering activities comply with cGMP and internal SOPs Review and approve engineering-related documents Qualification & Validation (CSV/Equipment/Utilities) Review And Approve: DQ, IQ, OQ, PQ protocols and reports Equipment and utility qualification documents Ensure: Qualification activities are scientifically justified Traceability from URS to qualification stages Verify equipment is fit for intended use Calibration & Preventive Maintenance Oversight Review And Approve: Calibration schedules and reports Preventive maintenance (PM) plans Ensure: Critical instruments are calibrated within due dates PM activities are performed and documented Assess impact of missed calibration/PM D. Deviation & Investigation Review Review And Approve: Engineering deviations (equipment breakdown, utility failure) Ensure: Proper impact assessment on product quality Robust root cause analysis (RCA) Verify adequacy of CAPA and effectiveness checks E. Change Control Management Review And Approve: Engineering change controls (equipment modification, utility changes) Ensure: Changes are risk-assessed Proper qualification/requalification is performed Verify no adverse impact on validated state F. Data Integrity & Compliance Ensure adherence to ALCOA+ principles Review: Equipment logbooks Electronic systems (BMS, SCADA, PLC audit trails where applicable) Identify and escalate data integrity risks G. Utility System Compliance Ensure Compliance Of: HVAC systems (temperature, humidity, pressure differentials) Water systems (Purified Water, WFI if applicable) Compressed air and gases Review: Monitoring data and trends Alert and action limit excursions H. Documentation & GDP Compliance Ensure All Engineering Documents Follow: Good Documentation Practices (GDP) Maintain: Complete, traceable, and audit-ready documentation Ensure Proper Recording Of: Maintenance, calibration, and breakdown activities I. Audit & Inspection Readiness Participate In: Internal audits Regulatory Inspections (US FDA, MHRA, WHO) Act as SME for engineering QA topics Support closure of audit observations J. Cross-Functional Coordination Coordinate With: Engineering & Maintenance team Production QA / IPQA / Validation Ensure alignment between engineering and quality requirements K. Training & Compliance Awareness Provide Training On: Engineering compliance requirements GDP and data integrity Guide engineering team on QA expectations Immediate reporting of observed non-compliance to IPQA In charge/ QA Head. Qualifications & Pre-Requisites B. Pharm/ M. Pharm/ M.Sc. With relevant experience in pharma. Must have knowledge of working on the engineering shop floor as an in-process quality assurance. Exposure to various regulatory bodies such as US FDA, EU-GMP, MHRA, TGA Exposure to specific dosage forms like OSD, Liquid Orals, Nasal (optional) Effective communication, Team coordination and work in collaboration within compliance Additional Notes: Role is expected to work in all shifts and all days of the week. Expected to visit Satara, Thane, or other manufacturing sites on need basis and as per business requirements.