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 current 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.