Quality Executive

1 week ago


Mumbai Maharashtra, India HIRINGHOUSE TECHNOLOGIES PVT LTD Full time

**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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