Qms

2 weeks ago

Baddi, India Maya Biotech PVT LTD Full time

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

- **Quality Management Systems (QMS)**:

- Develop, implement, and maintain the QMS in accordance with industry standards, such as ISO, cGMP, or other relevant regulations.
- Monitor and assess the effectiveness of QMS processes, ensuring they meet regulatory requirements and company policies.
- Lead the development and revision of SOPs, work instructions, and other quality-related documentation.
- **Regulatory Compliance**:

- Prepare for and participate in regulatory audits and inspections, including those by the FDA, or other global regulatory bodies.
- Address and resolve audit findings or observations, and implement corrective and preventive actions (CAPAs) as required.
- Ensure ongoing compliance with applicable regulations and standards, stay updated on changes, and interpret their impact on the QMS.
- **Quality Assurance**:

- Perform internal audits and support external audits to assess compliance with QMS and regulatory requirements.
- Review and approve validation protocols, reports, and change controls.
- Collaborate with cross-functional teams to address quality issues and implement continuous improvement initiatives.
- **Training and Development**:

- Develop and deliver training programs to ensure staff is knowledgeable about QMS procedures and regulatory requirements.
- Foster a culture of quality and regulatory awareness throughout the organization.
- **Documentation and Reporting**:

- Maintain accurate and complete records of quality activities, including audit reports, CAPAs, and compliance documentation.
- Prepare and present quality metrics, reports, and analyses to senior management.

**Qualifications**:

- **Education**:

- B. Pharma, M. Pharma, Bsc,Msc
- **Experience**:

- Minimum of 6 to 8 years of experience in Quality Assurance within the pharmaceutical or injectables industry.
- Demonstrated experience with Quality Management Systems (QMS) and regulatory audits.
- **Skills**:

- In-depth knowledge of cGMP, ISO standards, and other relevant regulatory requirements.
- Strong understanding of QMS principles and practices.
- Proven ability to manage and lead audit preparations and responses.
- Excellent problem-solving skills and attention to detail.
- Effective communication and interpersonal skills.

**Experience**:

- 7 YRS: 1 year (preferred)

Work Location: In person

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