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Quality Assurance Executive

2 weeks ago

Sola Ahmedabad Gujarat, India DF Pharmacy Ltd Full time

**Key Responsibilities**:

- **Quality Assurance & Compliance**:

- Perform quality checks on raw materials, in-process materials, and finished pharmaceutical products.
- Ensure that all products meet regulatory and company standards.
- Verify compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Standard Operating Procedures (SOPs).
- Participate in internal audits to assess compliance with quality standards.
- **Inspection & Testing**:

- Conduct physical and chemical tests on raw materials and finished products.
- Inspect packaging, labeling, and shelf-life requirements of products.
- Ensure accurate documentation of quality tests, including batch records, quality control forms, and non-conformance reports.
- Review product specifications and analytical methods for QC testing.
- **Process Monitoring & Improvement**:

- Monitor manufacturing processes to identify deviations and propose corrective actions.
- Implement quality control methods that can detect defects during the production process.
- Recommend and implement improvements to QC protocols and procedures.
- Support in process validations, method development, and stability studies.
- **Documentation & Reporting**:

- Maintain detailed records of quality inspections, testing results, and non-compliance incidents.
- Prepare and submit quality reports to senior management.
- Assist in the preparation of product quality reviews and documentation for regulatory inspections.
- **Collaboration & Training**:

- Work closely with the production and R&D teams to ensure alignment with quality standards.
- Train production staff on quality control techniques and company quality standards.
- Support cross-functional teams in the investigation of quality incidents and root cause analysis.
- **Regulatory Compliance**:

- Stay up-to-date on changes in industry regulations and quality standards (FDA, WHO, EU guidelines, etc.).
- Assist in preparing for regulatory inspections and external audits.
- Ensure that all quality control procedures are compliant with the latest regulatory requirements.

**Required Qualifications**:

- **Education**: Bachelor's degree in Pharmacy, Chemistry, Biotechnology, or related field. A Master's degree is preferred.
- **Experience**: Minimum 2-4 years of experience in a quality control/assurance role within a pharmaceutical or biotech company.
- **Knowledge**: In-depth understanding of GMP, GLP, and regulatory requirements (FDA, WHO, ICH guidelines, etc.).
- **Skills**:

- Strong analytical and problem-solving skills.
- Proficiency in quality control techniques, testing methods, and lab equipment (e.g., HPLC, GC, FTIR).
- Excellent communication and documentation skills.
- Ability to work under pressure and meet deadlines.
- Proficient in MS Office and quality management systems (QMS).

**Preferred Skills**:

- Experience with process validations and stability studies.
- Familiarity with statistical process control (SPC) and quality improvement tools.
- Certified Quality Auditor or relevant quality certifications.

Pay: ₹11,776.40 - ₹42,301.39 per month

**Benefits**:

- Paid time off
- Provident Fund

Schedule:

- Day shift

Supplemental Pay:

- Yearly bonus

Application Question(s):

- Do you have experience in Pharma or cosmetic industry?

**Education**:

- Bachelor's (required)

**Experience**:

- Quality control: 3 years (required)

Work Location: In person