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 StaffOperation and supervision activities of OSD department on a shift-to-shift basis to complete documentation in accordance with cGMP requirements.

• 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.

• Operate the machines and supervise the line and participate in Validation activities as per the protocol.

• Use Ensur for training (If user id is available).

• Maintains cGMP practices along with documentations in various records.

• Involvement in the processing and documentation of trial/Validation/project batches.

• Committed when fill the documents contemporaneous (on-line), Legible, Readable, Accurate and Original.

• 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.

• Machines and area cleaning shall be performed as per the respective procedure.

• Monitors and reports the unauthorized movement of workmen from line.

• Takes up the responsibilities of the immediate supervisor for the section in his absence.

• Prepared and Update the department SOPs / Participate in department SOP preparation.

• Reports on day-to-day basis activities in SAP system (If SAP user id is available).

• Participate in machine qualification activities.

• Checks all the calibration tags of equipment and instruments for their due date time to time.

• Knowledge and involvement in SFTI & 6S Activities.

• Knowledge and involvement in ISO 14000 & 13485.

• Checking of line clearance during batch /Product change over.

• Perform in-process checks as defined in Batch Manufacturing Record.

• Preparation of Material Return Note(MRN), Material Requisition Note(MRQN),

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• Review the Batch Manufacturing record and other quality documents.

• To ensure EHS (Environmental, Health and safety) related activities to be completed on time and to support EHS activities as per the requirements. To report near miss and incidences as observed as per EHS requirement.

• Any other activity from time to time which his supervisor / company feels appropriate.