QC Data Reviewer

Be the First to Apply 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 QC Data Reviewer Job Description Provide remote analytical support to the Piramal Sites, including the preparation and/or review of technical documents such as specifications, test methods and review of analytical data. Responsibilities also include the Quality control investigations. Review of analytical data generated in the analytical lab (QC/AS) including but not limited to cleaning verification/validation data, raw materials, intermediates, finished products, stability, and method validation data according to cGMP, GDP, in a timely manner and activity signoff in LIMS / Empower / QMS module and activity signoff per site procedures. Handling of Other LIMS activities. To coordinate with site for review activities and share the review deficiencies with site team for further actions. Create and/or review of Specification, Test procedure, lab equipment and instrumentation Calibration and Preventive Maintenance (PM) Reports, etc. as per site procedure. v Create and/ or review working test methods in compliance with compendia requirements and laboratory practices to support analytical testing. Perform trend analysis of release testing data to identify OOT results. To create and/or review QMS documents such as Change control and Quality control investigations. Review analytical data generated by external laboratories to ensure compliance with specifications and quality standards. Develop, revise and review stability protocols and documentation in accordance with ICH guidelines and product-specific requirements, prepare stability summary reports with statistical analysis and trending to evaluate data and ensure regulatory compliance and data integrity. Investigation drafting for Event, OOT and OOS. Routing the documents in Ensur application whenever required across the Piramal plants. To participate and support site during customer audits and regulatory inspection.