Senior Executive - Quality Control
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Role Overview
Job Responsibilities:** * Perform complex analytical testing of raw materials, in-process samples, and finished products using various analytical techniques (e.g., HPLC, GC, ). * Review and approve analytical data, test results, and laboratory documentation to ensure accuracy and compliance with cGMP, pharmacopoeial standards, and internal specifications. * Develop, validate, and transfer analytical methods in accordance with regulatory guidelines. * corrective and preventive actions (CAPA), and document findings thoroughly. * Operate, calibrate, and maintain sophisticated laboratory equipment, ensuring proper functionality and troubleshooting any issues. * Train and mentor junior QC analysts on analytical techniques, laboratory procedures, and quality standards. * Participate in internal and external audits, providing support and documentation as required. * Prepare and review standard operating procedures (SOPs), specifications, and other quality-related documents. * Contribute to continuous improvement initiatives within the QC laboratory to enhance efficiency, accuracy, and compliance. * Ensure compliance with all relevant safety regulations and company policies.
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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 Description
Job Responsibilities:** * Perform complex analytical testing of raw materials, in-process samples, and finished products using various analytical techniques (e.g., HPLC, GC, ). * Review and approve analytical data, test results, and laboratory documentation to ensure accuracy and compliance with cGMP, pharmacopoeial standards, and internal specifications. * Develop, validate, and transfer analytical methods in accordance with regulatory guidelines. * corrective and preventive actions (CAPA), and document findings thoroughly. * Operate, calibrate, and maintain sophisticated laboratory equipment, ensuring proper functionality and troubleshooting any issues. * Train and mentor junior QC analysts on analytical techniques, laboratory procedures, and quality standards. * Participate in internal and external audits, providing support and documentation as required. * Prepare and review standard operating procedures (SOPs), specifications, and other quality-related documents. * Contribute to continuous improvement initiatives within the QC laboratory to enhance efficiency, accuracy, and compliance. * Ensure compliance with all relevant safety regulations and company policies.
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