Executive - 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

Executive - Quality Control

Job Description

The proposed role is critical to support daily media preparation, Growth promotion test, accessories preparation, daily lab monitoring and daily FP MLT daily 5-6 samples primary and secondary analysis, Water daily 35-40 samples primary and secondary analysis. This position is required to replace Ms. Shreya Pradhana (Emp No. 70099742) to ensure timely release of related samples while maintaining quality and compliance standards.

Key Roles & Responsibilities

• Setting the analysis priorities based on the production planning in microbiology section.
• Analysis of Water, Raw Materials, Finished Products and Crossover Studies in microbiology section (If, required).
• Responsible for the environmental monitoring, daily verification of equipment’s as per the schedule.
• Responsible for the online completion of Analyst Hard books, Analytical Raw Data, Equipment usage log books, Protocols and Reports etc.
• Maintenance of Media preparation/reconciliation data, Culture etc.
• Responsible for daily balance verification, pH Meter daily calibration, daily temperature and relative humidity monitoring records.
• Responsible for planning of Calibrations and Preventive Maintenance activities for Autoclaves, Incubators, Laminar Air Flow, Microscopes, Analytical Balances, Ovens, TOC analyzer and pH Meter etc. as per the schedule in microbiology section.
• Responsible for intimation of any deviations/ out of specifications in microbiology section.
• Ensure Safe working conditions and clean environmental practices in microbiology section.
• Responsible for the preparing/reviewing of trending reports for water and environmental and others.
• Responsible for periodic validation activities for ovens, autoclave, incubators, LAF and air samplers.
• Responsible for the preparation of Protocols, Reports, SOP’s, Spec & STP’s and other documents related to microbiology section.
• Observe unsafe acts / conditions and take Corrective & Preventive actions immediately in the section.
• Impart SHE training to all respective persons and report any incident / accident / near miss / illness to the respective superiors in the microbiology section.
• Responsible for revision of documents updated as per the changes made to the pharmacopeias/regulatory documents.
• Responsible for crossover/method transfer activities and its closures.
• Identify unsafe conditions and unsafe acts and report to superiors.
• To sign all the documents connected with the activities under his control.
• In the absence of Superior, he/she is responsible for his / her activities / responsibilities.
• She should be familiar with the trouble shooting techniques in microbiology section.