QA Officer - Trade Generic,CDMO Pharma

Key Responsibilities:
Manage the overall Quality assurance and Quality Check of products Responsible to ensure that that all products meet the highest standards of quality, safety, and regulatory compliance for a new Trade Generics businessWork closely with the senior advisor & procurement manager for QA/QC of contract manufacturers & final productsInitially report to promoter and later to Ops & Supply Chain Head Experience5+ years of experience as a quality manager/ executive in the pharmaceutical industry, with strong knowledge of regulatory standards is must.Relevant roles: Quality Manage/ Quality executive of a pharmaceutical companyExperience with leading the audit/ inspection/ regulatory compliance efforts with contract manufacturers, for a new pharmaco is preferred.Role & ResponsibilitiesInspection & Audit of contract manufacturers :Quality Oversight Ensure that select CDMOs comply with GMP, ISO standards, and other regulatory guidelines applicable to the pharmaceutical industryConduct regular audits Ensure batch reviews & quality controls throughout the production processProduct Quality Assurance:On site Conduct extensive QC and batch reviews for product on the CDMO manufacturing siteOff site Conduct product reviews after receipt at warehouseRegulatory Compliance & Documentation :Drive regulatory compliances in terms of product & process quality; liaison with respective regulatory bodiesDocumentation - Proper documentation and compliance with product quality requirements for regulatory submissions and inspectionsAdditional InformationEnsure product quality and regulatory compliance for a new Trade Generics business.Collaborate on QA/QC of CDMOs and final products.Conduct audits, inspections, and product reviews.Ensure regulatory compliance and documentation.5+ years of pharmaceutical QA/QC experience with regulatory expertise.