QA Officer - Trade Generic, CDMO Pharma

Job Description

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 business Work closely with the senior advisor & procurement manager for QA/QC of contract manufacturers & final products Initially report to promoter and later to Ops & Supply Chain Head Experience 5+ 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 company Experience with leading the audit/ inspection/ regulatory compliance efforts with contract manufacturers, for a new pharmaco is preferred. Role & Responsibilities Inspection & Audit of contract manufacturers : Quality Oversight Ensure that select CDMOs comply with GMP, ISO standards, and other regulatory guidelines applicable to the pharmaceutical industry Conduct regular audits Ensure batch reviews & quality controls throughout the production process Product Quality Assurance: On site Conduct extensive QC and batch reviews for product on the CDMO manufacturing site Off site Conduct product reviews after receipt at warehouse Regulatory Compliance & Documentation : Drive regulatory compliances in terms of product & process quality; liaison with respective regulatory bodies Documentation - Proper documentation and compliance with product quality requirements for regulatory submissions and inspections Additional Information Ensure 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.