Executive / Senior Executive_Engineering QMS For Injectable plant

Role & responsibilities

Engineering QMS profile :

• Maintain Engineering QMS documentation, including SOPs, formats, checklists, logbooks, records, and controlled documents.
• Manage Engineering logbook stock, issuance, reconciliation, and archival as per document-control requirements.
• Control issuance and retrieval of approved Engineering formats and ensure availability of current versions at point of use.
• Ensure proper documentation, review, completeness, and traceability of Engineering records.
• Coordinate document preparation, revision, approval, effective-date implementation, and obsolescence of Engineering documents.
• Maintain records related to preventive maintenance, breakdown maintenance, calibration, utilities, HVAC, water systems, and critical equipment.
• Support Change Control, Deviation, CAPA, Risk Assessment, Qualification/Validation, and audit-related documentation.
• Ensure timely closure of Engineering documentation gaps, deviations, CAPAs, and audit observations.
• Support GMP, regulatory, customer, and internal audits by maintaining Engineering records and ensuring QMS readiness.
• Promote Good Documentation Practices (GDP), data integrity, and compliance across Engineering activities.