06/13/2025 updated
PM
100 % available
Sr.Manager Quality Assurance - Pharmaceutical Quality Specialist with 16+ years experience
Navi Mumbai, India
Worldwide
Master of Science in Organic ChemistrySoftware ApplicationsGood Manufacturing PracticesComplianceDatabasesDocument Management SystemsElectronic Common Technical DocumentForecastingMedicines and Healthcare Products Regulatory Agency (MHRA) GuidesPharmaceuticalsQuality ManagementRisk AnalysisSAP ApplicationsPharmaceutical RegulationsPublishing
Pharmaceutical Quality Assurance
Extensive experience in Quality, Regulatory, and Licensing functions with expertise in managing complex regulatory submissions, ensuring cGMP compliance, and optimizing quality systems.
Regulatory Compliance
Deep knowledge of cGMP (ICH, USFDA, MHRA) and pharma forecasting. Managed FDA licensing including WC, WHO-GMP, layouts, test licenses, and renewals.
Software Proficiency
Advanced proficiency in software applications such as eCTD publishing, SAP, and Master Control, alongside expertise in regulatory reporting and documentation.
Risk Assessment & Validation
Expertise in risk assessment, validation, and regulatory reporting. Conducted risk assessments using 6M and 5Y methods and validated equipment processes.
Document Management
Proficient in PDF (Version XI Pro) for document handling, bookmarks, and smart links. Validated Excel sheets and performed calculator validations.
Quality Management Systems
Experience with Master Control (Version 2023.1) and SAP handling. Quick to respond to queries with expertise in QMS databases.
Regulatory Documentation
Skilled in preparing and reviewing critical documents for USFDA, CEP, and ANDA submissions. Led regulatory submissions via PHARMAREADY, ensuring eCTD accuracy.
Extensive experience in Quality, Regulatory, and Licensing functions with expertise in managing complex regulatory submissions, ensuring cGMP compliance, and optimizing quality systems.
Regulatory Compliance
Deep knowledge of cGMP (ICH, USFDA, MHRA) and pharma forecasting. Managed FDA licensing including WC, WHO-GMP, layouts, test licenses, and renewals.
Software Proficiency
Advanced proficiency in software applications such as eCTD publishing, SAP, and Master Control, alongside expertise in regulatory reporting and documentation.
Risk Assessment & Validation
Expertise in risk assessment, validation, and regulatory reporting. Conducted risk assessments using 6M and 5Y methods and validated equipment processes.
Document Management
Proficient in PDF (Version XI Pro) for document handling, bookmarks, and smart links. Validated Excel sheets and performed calculator validations.
Quality Management Systems
Experience with Master Control (Version 2023.1) and SAP handling. Quick to respond to queries with expertise in QMS databases.
Regulatory Documentation
Skilled in preparing and reviewing critical documents for USFDA, CEP, and ANDA submissions. Led regulatory submissions via PHARMAREADY, ensuring eCTD accuracy.
Experience
Professional experience10+ years
Freelancer since2020
Languages
EnglishFluent
Project history
Led QA teams to ensure timely project releases, process improvements, and cGMP compliance. Developed compliance procedures, conducted performance testing, and provided regulatory support for submissions.
Led SOP revision and training initiatives, reviewed QMS documentation, coordinated with UK Qualified Persons, conducted audits, and provided CAPA recommendations.
Led QA initiatives to optimize team performance, managed cleaning validation, conducted risk assessments, audited QMS and GMP documentation, and represented the company in FDA audits.