Job Description
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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
Technical Staff
Job Description
Supervises quality products are being manufactured in conformance with c-GMP/safety and hygiene requirements on shift-to-shift basis. Maintains overall disciplines and productivity.
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- Allocates workmen for different workstations on shift-to-shift basis.
- Follow the gowning procedure and personnel hygiene as per SOP.
- Supervision of line operations, monitors speed of machine and output according to the run time.
- Maintains cGMP practices along with documentations in various records.
- Involvement in the packaging, filling and documentation of trial batches.
- Fills and checks BMR/BPR before submission to the superiors.
- Handles minor parametric setting issues in various machines and products.
- Imparts on job/ Classroom training to be impart to concern workmen and supervisor for SOP and cGMP systems.
- Monitors and reports the unauthorized movement of workmen from line.
- Initiate Change control, deviation and CAPA in electronic system as per the need.
- Preparation/revision of SOP, Document, Format in electronic system as per the need.
- Takes up the responsibilities of the immediate supervisor for the section in his absence.
- Reports on day-to-day basis activities in SAP system.
- Verifies the balances on daily and monthly basis.
- Participate in machine qualification activities as per the protocol.
- Checks all the calibration tags of equipment and instruments for their due date time to time.
- Checking/Cross checking of line clearance during batch change over.
- In process activity as defined in Batch Manufacturing and Batch Packaging Record.
- Preparation of Material Return Note (MRN), Material Requisition Note (MRQN), Line rejection Note (LRN) of Filling and packaging area.
- Review the Batch Manufacturing, Batch packaging record and other quality documents.
- Actively participate in Visual Inspector qualification activity and DMS.
- Align work with site EHS Management system includes compliance & act on ISO 14001 & ISO 45001.
- Identification of workplace related hazards & Risk include reporting of Unsafe Act, Unsafe Condition and Near miss.
- Perform work in line of safe work behavior & Strict vigilance on Behavioral aspect of team members.
- Active involvement to buildup safety culture in your respective workplace.
- Strict adherence & implementation of Existing control measures against identified Hazards to mitigate the level of risk.
- Active participation & involvement of others to buildup safety culture in respective workplace.
- Perform and ensure that workplace activity is align according to established procedure & instructions.
- Use and encourage other to use necessary & recommended PPE according to work in the area or work with machine / material / equipment.
Adopt and encourage to maintain good hygiene & Safe work practices & discipline in the work area.
