Quality Inspector, GMP Compliance & Batch Release
Overview
You will provide on-the-floor quality oversight for manufacturing, packaging, labeling, and distribution at Piramal Enterprises in Philadelphia. You will own batch record issuance, line clearances, and environmental monitoring reviews. You will ensure GMP and FDA compliance while collaborating with production and quality teams. This role offers direct impact on product safety and regulatory readiness, with shifts available on 1st or 3rd.
What You'll Do9
- 1Issue batch records aligned with the production schedule and perform potency calculations on SAP.
- 2Conduct line clearance and batch readiness assessments, verifying documentation, equipment status, and preventive maintenance records.
- 3Review Environmental Monitoring data for compliance with internal and regulatory standards, escalate critical alarms.
- 4Perform quality oversight for water system releases, raw material sampling, and AQL inspections of finished products.
- 5Review equipment logbooks and executed batch records to ensure GDP, GMP, and Data Integrity standards.
- 6Scan and upload batch records to SharePoint, prepare batch records, and execute first release of batches.
- 7Perform raw material reconciliation and investigations, review calibration activities in ProCal, and approve non-routine work orders in SAP.
- 8Draft and revise SOPs and deviation reports to ensure clarity and regulatory alignment.
- 9Conduct weekly quality surveillance, including facility inspections and audits of equipment maintenance to support audit readiness.
Requirements8
- 1Bachelor of Science in a relevant field.
- 21-3 years in pharmaceutical quality assurance, regulatory affairs, or GMP auditing.
- 3Prior experience in on-the-floor quality oversight or inspections in a regulated environment.
- 4In-depth knowledge of GMP, GDP, GLP, and international regulations (FDA, EMA).
- 5Strong analytical, investigative, and problem-solving skills with attention to detail.
- 6Excellent written and verbal communication and interpersonal skills.
- 7Proficiency in MS Office and quality management systems (QMS).
- 8Ability to travel to facilities for inspections as required.
Salary Insight
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