Quality Assurance Officer

7 days ago

Gota Ahmedabad Gujarat, India neza wellness Full time

**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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