Job Description

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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 - ProjectsResponsible for qualification documentation and execution (URS, DQ, IQ, OQ & PQ) for process, utility, HVAC and water systems as per GMP requirements, including coordination with QA, Engineering, Production, E&M and vendors. Manage TrackWise Change Controls, project drawings, P&IDs, layouts, BOQs and equipment datasheets, along with statutory drawings. Handle CAPEX documentation, PR/PO/GRN, bill tracking, CER closure and capitalization, ensuring complete audit-ready documentation and timely project handover to Maintenance.

• Preparation and execution of qualification documentation including URS, DQ, IQ, OQ and PQ for process equipment, utility equipment, HVAC and water systems as per GMP requirements.
• Coordination and follow-up for qualification activities with Engineering, QA, Production, E&M, vendors and other cross-functional teams.
• Review and compilation of qualification documents including protocols, reports, certificates, calibration records, manuals and supporting documents.
• Follow-up with vendors for timely submission of qualification-related documents, manuals, certificates, drawings and technical dossiers.
• Handling TrackWise Change Controls for review and approval of proposed changes in process systems and related documentation.
• Preparation and maintenance of Project Department SOPs as per QA requirements and ensuring compliance.
• Preparation and maintenance of site engineering drawings for Unit-I and Unit-II covering TSD, Production, Safety, E&M, QA and other functions.
• Preparation of P&IDs and conceptual layouts based on approved URS and project requirements.
• Preparation of BOQs based on P&IDs, layouts and approved project scope.
• Preparation of engineering equipment datasheets and drawings for Type-I&II projects.
• Preparation and coordinating Panchayat and Inspector of Factories drawings for the Digwal site.
• CAPEX documentation management including PR, PO, GRN, service entry, bill verification, bill tracking and capitalization.
• Tracking of PR, PO and GRN for ongoing projects and ensuring timely closure.
• Timely closure and capitalization of project CERs as per the approved project schedule.
• Compilation and closure of project documentation for audit readiness and regulatory compliance.
• Handover of completed projects to Maintenance along with approved drawings, qualification documents, manuals, certificates and other relevant technical documentation.

Bachelor of Engineering (Civil) (Inactive)