Quality Executive Trade Generics
Locations: Mumbai & Surat
Experience: 5 to 10 Years
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
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