Apprentice

4 days ago

Mahad, India Piramal Pharma Solutions Full time

To execute sampling and analysis of Raw materials along with relevant laboratory documentation.
- To execute analysis of finished goods, In-process, packing materials and cleaning samples along with relevant laboratory documentation.
- Result reporting after completion of analysis & relevant documentation.
- Before starting an analysis, following points (but not limited to) must be checked:

- Check all the instruments on the equipment required for the analysis are in working condition and are in calibrated state.
- Checking and ensuring proper status labels after confirming availability of all the requirements (as applicable) for analysis such as approved control procedure, analytical protocol, reference standards, chemicals, reagents, GC/HPLC columns, glassware, water preparation equipment, water bath, sonication baths, mobile phase bottle etc.
- Ensure the online documents pertaining to day-to-day analysis are efficiently completed in timely manner. Reporting the activities daily to immediate supervisor.
- Ensure timely calibration & preventive maintenance of equipment/instrument.
- Destruction of respective records & QC Samples like Retention samples of Raw Materials, analyzed samples.
- To take out the quality reports, Data / Results entry in SAP system.
- To prepare and maintain the working standards & documentation.
- Ensure timely raising and closure of deviations, quality events, change controls, OOS/OOT.
- To execute Analytical Method Validation / Transfer, cleaning validation as per approved procedure & protocol.
- Preparation and maintenance of Analytical data sheets and Excel spread sheets.
- Adequate knowledge of all equipment/instruments & their functioning in the laboratory & assist in equipment/instrument qualification activities.
- Ensuring the quality and integrity of all GxP data and documentation generated.
- Ensuring effective execution requirements of food regulations (US)-21 CFR Part 111.
- Ensure fully Engagement and Involvement regarding awareness, clarity maintained related to data integrity.
- Ensure the 21 CFR Part 11 compliance in the Laboratory.
- Effective implementation of practices like cGMP & GLP, ISO 9001, ISO 14001, ISO 22000, ISO 18001, HACCP and SQF in QC Dept.
- To follow and maintain the standard chromatographic practices.
- Ensuring good house-keeping and accident free working in the Laboratory.
- To perform safe Laboratory operations (as per MSDS) ensuring proper usage of PPEs, safe, secure storage of hazardous, toxic, explosive, corrosive, irritant materials.
- Ensure proper maintenance of logbooks in QC lab.
- To fulfill the analytical requirements of FSSAI regulation.
- To undergo assigned trainings on cGMP, HSE & departmental procedures / policies.
- To determine internal and external QEHS issues as well as needs and expectations of relevant interested parties and monitor the same.
- To implement QEHS policy & objectives.
- To ensure participation and consultation of worker.
- To identify & communicate incidents, QEHS non conformities, investigate and take corrective actions on the same.
- To ensure work permit system during maintenance activities.
- To implement QEHS continual improvement projects at site and monitor.
- To ensure disposal of waste.

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