Quality Inspector

About the role

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

The Quality Operations Inspector is responsible for providing on-the-floor quality oversight and support to ensure the compliance of manufacturing, packaging, labeling, and distribution operations with Piramal Standard Operating Procedures (SOPs) and applicable regulatory requirements. This includes adherence to Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), Data Integrity principles, and FDA regulations. The inspector plays a critical role in maintaining product quality, safety, efficacy, and regulatory compliance across operations.

Responsibilities

• Issue batch records in alignment with the production schedule to support timely manufacturing activities and Perform potency calculations as applicable.
• Conduct line clearance and batch readiness assessments, including verification of concurrent documentation, equipment status, and preventive maintenance records.
• Review and evaluate Environmental Monitoring (EM) data for compliance with internal standards and regulatory requirements.
• Perform BMS alarms review, acknowledgement and evaluate quality impact. Escalate critical alarms to Management.
• Perform quality oversight for water system releases used in operations.