Executive-QC

Piramal Pharma Limited; Turbhe; On-site; INR 300,000 - 460,000; Full time

Job summary

Piramal Pharma Solutions in India is seeking an Executive-QC to perform analysis of in-process, intermediate and stability samples, and to support cGMP-compliant documentation. The role involves UV and HPLC analyses, handling stability samples, and contributing to investigations of deviations and OOS results.

Shift rotations apply, and duties may evolve with senior guidance. The successful candidate will maintain high quality records, prepare protocols and reports, and ensure accurate reporting

Qualifications

• Perform analysis of in-process, intermediate and stability samples.
• Carry out UV and HPLC analyses per SOPs.
• Maintain cGMP-compliant records and documentation.
• Support investigations related to deviations and OOS results.

Responsibilities

• Perform analysis of in-process, intermediate, stability, and hold-time study samples.
• Conduct UV and HPLC analysis as per SOPs and in-house procedures.
• Handle charging and withdrawal of stability samples.
• Prepare stability study protocols and reports.
• Maintain all analytical records and documentation as per cGMP requirements.
• Support investigations related to deviations and Out of Specification (OOS) results.
• Perform reporting authority responsibilities in their absence.
• Work in rotating shifts as required.
• Perform other duties assigned by seniors.

Skills

In-process analysis

Stability testing

Documentation

Tools

HPLC

UV

Job description

Division Piramal Pharma SolutionsPiramal 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-QCJob Description

• Perform analysis of in-process, intermediate, stability, and hold-time study samples.
• Conduct UV and HPLC analysis as per SOPs and in-house procedures.
• Handle charging and withdrawal of stability samples.
• Prepare stability study protocols and reports.
• Maintain all analytical records and documentation as per cGMP requirements.
• Support investigations related to deviations and Out of Specification (OOS) results.
• Perform reporting authority responsibilities in their absence.
• Work in rotating shifts as required.
• Perform other duties assigned by seniors.

cGMP Regulations, High-Performance Liquid Chromatography (HPLC), OOS Investigations, Out of Specifications, Stability Protocol