Quality Assurance Officer
2 weeks ago
**Job Title: Quality Assurance Specialist**
**Location: Noronic Pharmaceuticals, Gota, Ahmedabad,**
**Key Responsibilities**:
**Quality Documentation**:
Prepare and maintain **BMR, BPR, MFR, COA, MOA,** and **Process Validation Reports**.
Review and maintain **CAPA, Change Control, FMEA, FTA, and SPECT reports**.
Ensure all documents align with **ICH Guidelines**, and **regulatory**requirements.
**Quality Monitoring**:
Conduct audits and inspections.
Review test results and prepare reports on deviations and investigation outcomes.
Monitor and report on stability protocols **(SPECT).**
**Process Improvement**:
Collaborate with teams for continuous improvement initiatives.
Lead Root Cause Analysis **(RCA) and CAPA processes.**
**Qualifications**:
**Education**: Bachelor’s degree in a related field (Quality Management, Engineering, Science).
**Experience**: 1 - 3 years in quality assurance or related field.
**Skills**:
Proficient in preparing BMR, BPR, MFR, COA, MOA, CAPA, Change Control, FTA, EMA, and Process Validation reports.
Knowledge of ICH Guidelines, and regulatory standards.
Strong attention to detail and problem-solving abilities.
Experience with quality management systems and documentation tools.
**Job Types**: Full-time, Permanent
Pay: From ₹250,000.00 per year
**Benefits**:
- Health insurance
- Provident Fund
Schedule:
- Day shift
- Morning shift
Supplemental Pay:
- Yearly bonus
Work Location: In person
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