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 -
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.
