Executive / Sr Executive

OneSource CDMO is looking for Executives/ Sr Executives in Engineering & Projects team for DP Process Equipment

Pls find the Job Description as below.

Primary Responsibility

Strategic :

• Aware of GDP requirements related to Projects & Engineering.
• Update & aware of cGMP requirement.
• Plan & work towards the target set by the management based on business needs.

Operational :

• Responsible for operation & maintenance of Drug product process equipment like Vials, Tunnel, Autoclave, PFS, Cartridges.
• Perform preventive maintenance and breakdown maintenance Drug product process equipments.
• Operation and maintenance of filter cleaning and equipment.
• Good Documentation and CGMP practices.
• Monitoring of outsource agency for plant operation. Review & coordinate for finalization of agreements.
• Preparation/Review/Training of SOP, Preventive Maintenance, Break down Maintenance, Schedule, Planning.
• Knowledge of plant safety & cGMP requirements. Audit & Statutory Compliance.
• Coordination with user departments & plan for Preventive/Breakdown maintenance.
• Ensure smooth operation of plant & machinery to avoid breakdowns & production loss.
• Plan for required spare parts inventory, AMC and PR Creation in SAP.
• Prepare/ Review/ Execution of SLIA, URS, DQ, QRM, CLIA, FAT, SAT, IQ, OQ & Support for PQ.
• Audit and statutory compliance.
• Computer skills including auto CAD and Microsoft project.
• Responsible for handling of controlled documents such as SOPs, logbook and qualification protocol etc.,
• Document Edit, Review & Approval in EDMS system.
• Responsible to ensure preventive maintenance of the equipment is completed as per schedule and review the preventive maintenance schedule as per SOP.

People:

• Coordination & working with CFT, external vendors, senior leadership team and reporting of activities.
• Coordination with AMC & OEM vendors for maintenance support.