Job Description

Quality Operations Inspector -I

Position Summary

The Quality Assurance 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.

Key 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.
• Perform raw material Sampling and AQL inspection of finished products.
• Review equipment logbooks and executed batch records to ensure adherence to GDP, GMP, and Data Integrity standards.
• Scan reviewed batch records and upload to share point.
• Prepare batch records and perform first release of batches.
• Perform Raw material reconciliation and investigation.
• Review and approve Calibration activities in ProCal.
• Perform QA review and approval of non-routine workorders in SAP.
• Draft, revise, and review Quality Assurance SOPs and deviation reports to ensure clarity, accuracy, and regulatory alignment.
• Conduct weekly quality surveillance activities, including facility inspections, environmental monitoring checks, and audits of equipment maintenance and GMP practices to support continuous audit readiness.
• Complete all assigned training on SOPs and job-related tasks in a timely manner.
• Stay current with industry trends, updates to regulatory requirements, and emerging quality standards.
• Perform all other activities as assigned by Manager

Experience:

• 13+ years of experience in pharmaceutical quality assurance, regulatory affairs, or GMP auditing.
• Prior experience in providing on-the-floor quality oversight and conducting inspections or working in a regulated pharmaceutical environment preferred.

Skills:

• In-depth knowledge of GMP, GDP, GLP, and relevant international regulations (FDA, EMA).
• Strong analytical, attention to detail investigative, and problem-solving skills.
• Excellent communication (written and verbal) and interpersonal skills.
• Proficiency in MS Office and quality management systems (QMS).
• Ability to travel to facilities for inspections (as required).

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