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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
Senior Executive-QA
Job Description
IPQA Senior Executive is responsible for ensuring that manufacturing and other processes comply with cGMP (current Good Manufacturing Practices) and internal quality standards. The individual actively monitors in-process operations, conducts line clearance, reviews batch documentation, and supports regulatory compliance to maintain product quality, safety and efficacy.
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Conduct in-process quality assurance (IPQA) checks across various areas of the facility to ensure compliance with quality standards.
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Ensure effective implementation of systems and procedures in accordance with current Good Manufacturing Practices (cGMP) across the site, along with proper documentation.
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Ensure line clearance during product changeovers to prevent mix-ups and contamination.
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Verify Standard Operating Procedures (SOPs) and ensure procedural compliance on the shop floor
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Verify Batch Manufacturing Records (BMR), Equipment Cleaning Records (ECR), logbooks, and other documentation for completeness and contemporaneous entries.
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Identify and report potential risks of contamination or cross-contamination within the facility.
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Ensure compliance with data integrity principles during all site activities.
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Monitor and verify that materials are stored under defined conditions and appropriately labeled.
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Ensure that deviations are reported in real-time and documented as per procedure.
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Conduct periodic reviews of quality records to ensure accuracy and completeness.
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Train shop floor personnel on SOPs, protocols, and quality standards.
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Review and trend alarm data as required to support quality and compliance.
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Manage Quality Management System (QMS) activities including documentation and follow-up.
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Review schedules and records related to validation, qualification, calibration, and preventive maintenance (PM).
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Conduct internal audits (self-inspections) to assess compliance and identify areas for improvement.
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Prepare and review SOPs to ensure clarity, accuracy, and regulatory compliance.
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Review Annual Product Reports (APR) to assess product performance and compliance.
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Support Environment, Health, and Safety (EHS) activities, ensure timely completion of EHS tasks, and report near misses and incidents as per EHS guidelines.
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Perform any other responsibilities assigned by the Head of Department (HOD).
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Follow Good Manufacturing Practices (GMP) and safety guidelines.
