Establishes and continuously improves the engineering QMS for pharmaceutical manufacturing. Responsibilities include SOP and document control, deviation and CAPA management, change control, qualification and validation support, preventive maintenance and calibration oversight, audit readiness, GMP training, risk management, engineering records, and procurement coordination. Ensures compliance with cGMP, Schedule M, WHO-GMP, ISO, and related regulatory requirements.
Position: QMS Executive – Engineering Department
Purpose of the Role:
To establish, maintain, and continuously improve the Engineering Quality Management System (QMS) in compliance with cGMP, Schedule M, WHO-GMP, ISO and other applicable regulatory requirements. The role ensures that all engineering documentation, Preventive maintenance, supporting to qualification, validation activities and quality records are properly controlled and compliant.
Key Responsibilities
Engineering QMS:
Prepare, review, revise, and maintain Engineering SOPs, formats, work instructions, and policies.
Ensure timely review and revision of controlled documents.
Maintain document control as per QMS requirements.
Deviations, CAPA & Change Control
Initiate and investigate engineering deviations.
Prepare root cause analysis (RCA) using appropriate quality tools.
Implement and monitor CAPA effectiveness.
Coordinate engineering change control activities.
Qualification & Validation
Prepare and review DQ, IQ, OQ, PQ protocols and reports.
Support qualification of utilities, equipment, and HVAC systems.
Coordinate periodic requalification activities.
Preventive Maintenance & Calibration
Ensure preventive maintenance schedules are followed.
Monitor calibration status of engineering instruments.
Maintain PM and calibration records for audit readiness.
Audit & Compliance:
Participate in internal, customer, and regulatory audits.
Prepare engineering documentation required during audits.
Ensure timely closure of audit observations.
Documentation:
Maintain engineering logbooks and records.
Ensure proper documentation of maintenance, breakdowns, and utility operations.
Archive engineering records as per document retention policy.
Training:
Conduct QMS and GMP training for engineering personnel.
Maintain training records and competency assessments.
Risk Management:
Perform Quality Risk Management (QRM) for engineering activities.
Support implementation of risk mitigation measures.
Timely closure of deviations and CAPAs.
Change control closure within target timelines.
PM and calibration compliance.
Audit observation closure.
Documentation compliance.
Indenting:
Prepare indent for all engineering related items
Coordinate with procurement as well as Engineering team for any hurdles
Qualification and Experience:
B.Pharma
Experience
3–5 years of experience in Engineering QMS within a pharmaceutical, biotechnology manufacturing company.
Required Skills
Good knowledge of cGMP, Schedule M, WHO-GMP, and regulatory requirements.
, deviations, CAPA, change control, and document management.
Knowledge of qualification and validation activities.
Strong documentation and communication skills.
Proficiency in Microsoft Office and electronic QMS systems.
Yashraj Biotechnology Limited Navi Mumbai, Maharashtra, IND Office
Navi Mumbai, India
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