Dy. Manager - Quality Control

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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

Dy. Manager - Quality Control

Job Description

JD - Deputy Manager (QC)

• To execute sampling and analysis of Raw materials along with relevant laboratory documentation.
• To execute analysis of finished goods, packing materials, In-process 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.
• Establishing, validating and implementing all QC procedures.
• Evaluating, maintaining and storing reference standards for substances.
• 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/ OOE.
• 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 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.