Quality Control Executive (Piramal)

Roles and Responsibilities

Job Description

JD - Executive Quality Control

• To execute analysis of finished goods / Stability samples / Raw materials / Packing materials/ In-process and cleaning samples along with relevant laboratory documentation.

• Intimation & 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.

• Execution of Analytical method validation, cleaning validation of Products.

• 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 HPLC and GC column and related 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.