Executive / Senior Executive_Engineering QMS For Injectable plant

Amneal Pharmaceuticals LLC; Ahmedabad District; Presencial; INR 900.000 - 1.300.000; Tempo integral

Resumo da vaga

Amneal Pharmaceuticals LLC is seeking an Engineering QMS specialist to maintain documentation, manage logbooks, and ensure controlled documents are current and accessible at use points.

You will support GMP, audits, change control, CAPA, risk assessment, and validation, promoting GDP and data integrity within Engineering activities.

Responsabilidades

• 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.

Descrição da vaga

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.