Quality Assurance Executive

2 weeks ago

Ahmedabad Gujarat, India Nexus Pharmachem Pvt. Ltd. Full time

Review and update standard operating procedures (SOPs) to align with changing regulations and best practices. Documentation And Records Management
- Maintain and manage documentation related to quality assurance activities, including batch records, investigation reports, change controls, and validation documentation.
- Ensure accurate and timely completion of all quality-related documentation. Product Quality Control
- Investigate product non-conformances, deviations, and customer complaints to identify root causes and implement appropriate corrective and preventive actions (CAPAs).
- Knowledge of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant quality standards.
- Making decisions on batch disposition and product recall based on root cause identification.
- Reviewing and approving compliance reports following external (customer/regulatory) audits and corporate audits to ensure compliance.
- Preparing and implementing quality assurance policies and procedures and ensure that standards and safety regulations are observed.
- Timely completion of APQR related activity
- Prepared & Review of Validation protocol and report (like Process Validation, Cleaning Validation, Analytical Method Validation,)
- Handling of Market Complaint and Related Compliance
- Handling of out of specification and suitable investigation
- Handling of Deviation and Incident
- Prepared BMR, SOP, Protocols etc.
- Compliance of Vendor Audit, Regulatory Audit etc.

Skills & Qualification

**Education**:
UG: B.Sc / B.Pharm

PG: M.Sc / M. Pharm

Knowledge of computer competence, including database management

Minimum Experience Required: 1 - 3 Year

CV Required

**Job Types**: Full-time, Permanent

**Salary**: ₹150,000.00 - ₹300,000.00 per year

**Benefits**:

- Flexible schedule
- Leave encashment

Schedule:

- Day shift

Supplemental pay types:

- Yearly bonus

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