Qc/qa Officer

1 week ago

Lower Parel Mumbai Maharashtra, India EDGEPHARMA Full time

**Job Summary**:
**Responsibilities**:

- Develop and implement quality assurance processes and procedures to ensure that products meet regulatory requirements and quality standards.
- Conduct internal audits of quality systems and processes, and develop corrective action plans to address any deficiencies.
- Develop and implement training programs for quality assurance staff and other departments on quality processes and procedures.
- Maintain documentation and records related to quality assurance processes and procedures, and ensure that they are accurate and up-to-date.
- Ensure that all quality-related documentation, such as standard operating procedures, work instructions, and forms, are properly controlled and maintained.
- Coordinate with other departments, such as R&D, production, and regulatory affairs, to ensure that quality requirements are met throughout the product lifecycle.
- Participate in the development of new products and technologies, providing guidance on quality requirements and ensuring that quality is built into the product from the beginning.
- Participate in external audits and inspections, and develop corrective action plans to address any findings.

**Qualifications**:

- **Master’s degree** in biotech, biochemistry, microbiology or life sciences.
- **Minimum of 1 - 2** years of experience in a Quality Assurance, preferably in the IVD industry.
- Strong understanding of quality management systems, such as ISO 13485 and FDA, MDR 2017.
- Knowledge of regulatory requirements for medical devices, such as the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
- Experience in conducting internal audits and implementing corrective actions.
- Excellent communication and leadership skills.
- Ability to work collaboratively with other departments and teams.
- Strong problem-solving skills and attention to detail.
- Proficient in Microsoft Office and quality management software.

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

**Salary**: ₹200,000.00 - ₹350,000.00 per year

**Benefits**:

- Commuter assistance
- Leave encashment
- Provident Fund

Schedule:

- Day shift

Supplemental pay types:

- Yearly bonus

Work Location: In person

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