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 current 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.

📌 QA Officer - Trade Generic,CDMO Pharma (Mumbai)
🏢 Miracle Industrial
📍 Mumbai