Technical Staff - Production

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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 - Production
Job Description
Primary and secondary technician for blister operation.
· Allocates workmen for different workstations on shift-to-shift basis.
· Ensure no stoppage of operation / machines due to non-availability of manpower and any kind of machine breakdown.
· Handle the blister machine CAM and IMA-PG independently.
· Handle Cartonator machine CAM, PAM PACK-VP-120, HICART independently.
· Participates in Validation /Trial / qualification activities as per the protocol whenever required.
· Checks and cross-verify line clearance during Batch/Product changeover.
· Maintains c-GMP practices along with documentation in various records.
· To maintain good hygiene, safety practices and disciplines.
· Fills in-process parameters/Reconciliation in packaging documentation.
· Involve in investigation of event/ market complaints and implementation of CAPA.
· Performed the machine setting issues and troubleshooting.
· Monitors the speed of the machine and output according to the run time.
· Imparts online/ Classroom training to the workmen/Technical staff and other employee for SOP and cGMP systems.
· Monitor and reports the unauthorized movement of workmen from the line.
· Support to site DICO (Data integrity compliance officer) for monitoring and implementation of actions related to Data Integrity awareness at site.
· Reports on day-to-day basis activities in SAP system (If SAP user id is available).
· Verify the balances on daily and monthly basis.
· Maintenance and calibration of various instruments and equipment.
· Check all the calibration tags of equipment, instruments, and fire extinguishers for their due date time to time.
· Knowledge and involvement in DMS, OEE and other KPIs Activities.
· Knowledge and involvement in ISO 14000 & 13485 and EHS compliance (Near Miss reporting/Learning Incident, UA & UC).
· Prepare and cross-verify the material return note (MRN) after the completion batch/product campaign.
· Prepare the line rejection note (LRN), material requisition note (MRQN) wherever required.
· Perform and ensure that activities are carried out as per hazard identification and risk assessment (HIRA) and site EHS procedure (SEP).
· Any other activity from time to time which his supervisor/company feels appropriate.
Take-up the responsibilities of the immediate supervisor for the section in his absence.