Trainee Officer

2 days ago

India Zydus Group Full time

Department
- MORAIYA
- Job posted on
- Feb 20, 2025
- Employment type
- T-T7-Trainee-HO Staff

**Job Summary**:
The Assistant Manager in the Manufacturing Science & Technology is responsible for overseeing and conducting investigations into manufacturing deviations, non-conformances, and other quality-related issues. This role ensures compliance with current Good Manufacturing Practices (cGMP), regulatory requirements, and company policies.

**Key Responsibilities**:

- **Investigation Management**: Lead and manage investigations into manufacturing deviations, non-conformances, and other quality issues. Ensure thorough root cause analysis and timely completion of investigation reports.
- **Corrective and Preventive Actions (CAPA)**: Develop and implement CAPA plans based on investigation findings. Monitor the effectiveness of CAPA to prevent recurrence of issues.
- **Compliance**: Ensure all investigations and related activities comply with cGMP, regulatory requirements, and company policies. Maintain accurate and detailed documentation.
- **Training and Development**: Provide training to manufacturing staff on investigation procedures, root cause analysis, and CAPA. Mentor and develop team members to enhance their skills and knowledge.
- **Collaboration**: Work closely with cross-functional teams, including Quality Assurance, Production, and Regulatory Affairs, to ensure effective communication and resolution of quality issues.
- **Continuous Improvement**: Identify opportunities for process improvements based on investigation findings. Implement changes to enhance manufacturing processes and product quality.
- **Reporting**: Prepare and present investigation reports to senior management. Provide regular updates on the status of investigations and CAPA implementation.

**Qualifications**:

- **Skills**: Strong analytical and problem-solving skills. Excellent communication and interpersonal skills. Proficiency in using investigation tools and methodologies (e.g., DMAIC, Fishbone Analysis).
- **Knowledge**: In-depth knowledge of cGMP, regulatory requirements, and quality management systems. Familiarity with pharmaceutical manufacturing processes and equipment.

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