Quality Executive
1 week ago
**Locations : Mumbai & Surat**
**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
**Mandatory Skills**
Quality Assurance, Quality Check, Pharmaceutical Industry, Audit, Inspection, Regulatory Compliance, CDMO
**Job Types**: Full-time, Permanent
Pay: ₹83,000.00 - ₹125,000.00 per month
Schedule:
- Day shift
Application Question(s):
- Years of experience as a quality manager/ executive in the pharmaceutical industry?
- Years of experience with leading the audit/ inspection/ regulatory compliance?
- Current Location?
Work Location: In person
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