Executive-QC

Piramal Pharma Ltd; Thane; On-site; INR 250,000 - 420,000; Full time

Job summary

Piramal Pharma Solutions is seeking a detail-oriented Executive-QC to perform sampling and analysis of in-process, stability, and hold-time study samples using UV and HPLC in a cGMP-compliant environment.

You will prepare stability protocols, reports, and maintain documentation while supporting deviations and OOS investigations. The position requires flexibility for rotating shifts and adherence to SOPs.

Qualifications

• Experience in sampling and analysis of in-process, intermediate, stability, and hold-time study samples.
• Proficiency with UV and HPLC analyses as per SOPs.
• Maintain cGMP-compliant documentation and support investigations.
• Work in rotating shifts as required.

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

UV analysis

HPLC analysis

cGMP documentation

OOS investigations

Rotating shifts

Tools

HPLC instrument

UV spectrophotometer

Job description

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-QC

Job Description

Responsible for sampling and analysis of in-process, intermediate, stability, and hold-time study samples using UV and HPLC as per SOPs. Prepare stability protocols and reports, maintain cGMP-compliant documentation, support deviation and OOS investigations, and perform other assigned QC activities, including rotating shifts.

• 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