Technical Staff - Production

Piramal Pharma Ltd; Dhar; On-site; INR 300,000 - 420,000; Full time

Job summary

Piramal Pharma Ltd seeks a Technical Staff for Production to support sterile manufacturing and related documentation. The role requires ensuring compliant operations, participating in validations, and maintaining GMP records on a shift basis.

Responsibilities include supervising line activities, training staff on SOPs and cGMP, managing BMRs, and ensuring smooth machine operation with timely documentation and batch records review.

Qualifications

• B.Sc or B.Pharma, full-time education required.

Responsibilities

• Allocates workmen for different workstations on shift basis.
• Ensure no stoppage of operation due to manpower unavailability or machine breakdown.
• Supervises line operations and participates in validation activities per protocol.
• Maintains cGMP practices and documents in records.
• Involvement in processing and documentation of trial batches.
• Fills and checks BMR before submission to superiors.
• Handles minor parameter settings on various machines and products.
• Monitors machine speed and output during run time.
• Provides on-the-job and classroom training on SOP and cGMP systems.
• Imparts induction activity to new joining staff.
• Monitors unauthorized movement of workers from line.
• Acts as section supervisor in his absence and supports SOP preparation.
• Reports day-to-day activities in SAP (if user id available).
• Performs line clearance checks during batch changeover and assists in batch records review.
• In-process testing as defined in Batch Manufacturing Records.
• Prepares MRN/MRQN/LRN for processing area and reviews batch manufacturing docs.

Education

B.Sc / B. Pharma

Job description

Job Description

Technical Staff - ProductionJob Description Well-versed in sterile product manufacturing techniques, including drug manufacturing, autoclaving, FFS (Form–Fill–Seal) filling, aseptic filtration, and other processing operations. Responsible for executing manufacturing activities in the Sterile Department on a shift-to-shift basis and completing all documentation in accordance with cGMP requirements.

Key Responsibilities

• 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.
• Supervises the line operations and participate in Validation activities as per the protocol.
• Maintains c-GMP practices along with documentations in various records.
• Involvement in the processing and documentation of trial batches.
• Fills and checks BMR before submission to the superiors.
• Handles minor parametric setting issues in various machines and products.
• Monitors speed of machine and output according to the run time.
• Imparts on job/ Classroom training to the concern workmen and supervisor for SOP and cGMP systems.
• Imparts induction activity to all new joining.
• Monitors and reports the unauthorized movement of workmen from line.
• Takes up the responsibilities of the immediate supervisor for the section in his absence.
• Helps section in charge in preparation of SOP.
• Reports on day-to-day basis activities in SAP system. (If SAP user id is available)
• Verifies the balances on daily and monthly basis.
• Participate in machine qualification activities.
• Checks all the calibration tags of equipment, instruments and fire extinguisher for their due date time to time.
• Knowledge and involvement in Daily Management System.
• Knowledge and involvement in ISO 14000 & 13485.
• Any other activity from time to time which his supervisor / company feels appropriate.
• Checking of line clearance during batch change over.
• In process testing as defined in Batch Manufacturing Record.
• Preparation of Material Return Note (MRN), Material Requisition Note (MRQN), Line rejection Note (LRN) of Processing area.
• Review the Batch Manufacturing and other quality documents.

Essential Qualification

B.Sc / B. PharmaFull time