Executive-Engineering

piramalpharma; Mahad; On-site; INR 700,000 - 900,000; Full time

Job summary

Piramal Pharma Solutions in Maharashtra is seeking an Executive-Engineering to uphold the plant's quality system and ensure data integrity.

You will prepare/revise SOPs, ensure GMP/GDP compliance, and maintain ALCOA+ data traceability, while coordinating qualification activities (DQ/IQ/OQ/PQ) and HVAC/utility qualifications.

This role also drives documentation control, calibration, preventive maintenance, and QEHS improvements, with strong emphasis on audit readiness and PPE adherence.

Qualifications

• Role requires ensuring data integrity.
• GMP/GDP compliance exposure.
• Experience with QA/QMS processes.

Responsibilities

• Produce a quality product and maintain the plant quality system.
• Ensure ALCOA+ data traceability and proper documentation.
• Prepare and coordinate the preparation/revision of SOPs.
• Ensure engineering documentation complies with GMP, GDP and site SOP requirements.
• Coordinate documentation for qualification/validation activities (DQ/IQ/OQ/PQ, HVAC qualification, utilities).
• Maintain calibration records, reports, certificates, and supporting documents.
• GMP audit compliance to internal and external audits/inspections.
• Lead QEHS initiatives and coordinate with the Manager on maintenance-related activities.

Job description

Division

Piramal Pharma Solutions Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.For more details, please visit : www.piramalpharmasolutions.com

Job Title

Executive-Engineering Job Description

• JD - Executive (Engineering) Responsible for producing a quality product and responsible for maintaining a quality system in the plant.
• Ensuring Data Integrity.
• Documentation and Qualifications.
• Prepare and coordinate the preparation/revision of SOPs.
• Ensure engineering documentation complies with GMP, GDP, data integrity, and site SOP requirements.
• Verify that documents are complete, accurate, legible, traceable, and properly approved.
• Ensure ALCOA+ principles are followed wherever applicable.
• Prepare and maintain engineering documentation for Change Controls, CAPA, Deviations, Risk assessments.
• Coordinate documentation for qualification/validation activities DQ, IQ, OQ, PQ, Requalification, HVAC qualification, Utility qualification
• Maintain approved protocols, reports, certificates, calibration records, and supporting documents.
• Ensure deviations observed during qualification are properly documented and tracked.
• Maintain proper document traceability and revision history.
• Review of Calibration and Preventive Maintenance activities as per the schedule.
• GMP audit compliance to all internal & external audits & inspections.
• Allocation of manpower.
• Routine breakdown maintenance.
• Procurements of spare parts and inventory monitoring.
• Housekeeping record monitoring.
• Coordination with the Manager for various maintenance-related activities.
• QMS activities.
• To determine internal and external QEHS issues as well as the needs and expectations of relevant interested parties and monitor the same.
• To implement EQHS policy and objectives
• To ensure the participation and consultation of workers
• Ensure the use of PPE.
• To identify and communicate incidents. QEHS non-conformities investigate and take corrective actions on the same.
• To ensure the work permit system during maintenance activities.
• To implement QEHS continual improvement projects at the site and monitor.
• To ensure disposal of waste.