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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
Senior Executive-Engineering
Job Description
Handle the shift operation and maintenance of utilities to provide uninterrupted services and
ensuring cGMP and safety compliance .
Key Roles/Responsibilities:
To handle the shift operation and complete related documentation as required by SOP.
To achieve the targeted production, ensure smooth, efficient, uninterrupted and trouble-free operation and maintenance of water plant, HVAC and other utility equipment as per SOPs. To implement best practices to comply quality, safety & regulatory requirements.
To Prepare, ensure and monitor compliance of SOPs and related documentation of engineering department.
To initiate Change controls and Deviations, CAPA in electronic system as per the need.
To check & monitor operation, filter cleaning, filter replacement and preventive maintenance activity of HVAC system as per SOP.
To check & review Utility, water system and HVAC Log books
To keep awareness of operational standards (ISO 14001, ISO 45001 & 13485).
To follow the regulations of various agencies (USFDA, EU, TGA, MHRA, ANVISA, WHO, Schedule M etc.).
To participate in qualification & requalification of machine/equipment and functional support for qualification, validation and calibration activity.
Active participation in DMS, OE and EHS activities and engagement in the process.
To execute Preventive maintenance plans of respective area, and complete related documentation as per SOP.
To ensure good documentation and record keeping.
To ensure compliance of service floor activity.
To allocate jobs to workmen and supervise work for quality of job and timely completion.
To identify repeated breakdown and report and plan for corrective action along with engineering manager to avoid recurrence.
To provide guidance and support to executives and workman.
To impart induction activity to all new joiners.
To ensure proper working of HVAC systems & air conditioning units.
To raise purchase requisition for spares and required material in consultation with engineering manager.
To identify consumables and frequently used spare for each machine and plan in coordination engineering manager for inventory of such spares.
To check and approve incoming engineering goods.
To ensure legal/statutory compliance related to utility equipment.
To execute and complete project, area renovation work within scheduled timeframe.
To identify area of energy conservation and take operational and technological measures for efficient utilization of energy.
To maintain low engineering costs & ensure they remain with reasonable variance of sanctioned budget.
