Job Description

Contact : Charles Christian || 6351557887 || charles@srisaioverseas.com

Position Details:
Job Role: QMS Officer

Experience Required : 2-4 Years

Location : Baroda, Gujarat

Qualifications : B.Pharm/M.Pharm

"MUST HAVE EXPERIENCE IN USFDA AND WHO AUDIT"

:

The QMS Officer is responsible for overseeing the pharmaceutical quality management system to ensure compliance with industry standards and regulatory requirements. The role involves managing documentation, conducting internal audits, monitoring key performance indicators (KPIs) for quality, and ensuring continuous improvement in manufacturing and operational processes.

Key Responsibilities:

1. Quality Management System (QMS) Implementation:

• Develop, implement, and maintain the QMS framework.
• Ensure all processes comply with regulatory and GMP requirements.
• Oversee periodic updates and changes in QMS documentation.

2•. Documentation and Record Control:•

• Manage QMS documentation, including SOPs, batch records, quality manuals, and logs.
• Ensure timely review, approval, and distribution of quality-related documents.
• Control the archival, retention, and disposal of documents according to industry standards.

3.Audits and Compliance:

• Conduct internal audits to verify compliance with regulatory standards and identify areas for improvement.
• Coordinate and support external audits and inspections by regulatory agencies.
• Ensure timely closure of audit findings and implement corrective and preventive actions (CAPA).

4. CAPA Management:

• Investigate deviations, non-conformances, and complaints to identify root causes.
• Initiate CAPAs to address issues, monitor effectiveness, and prevent recurrence.
• Track and report CAPA status to senior management.

5. Training and Education:

• Train employees on QMS policies, procedures, and regulatory standards.
• Develop training materials and conduct training sessions for quality-related processes.
• Maintain training records for all staff involved in QMS activities.

6. Risk Management:

• Conduct risk assessments to identify potential quality risks in production and operational processes.
• Develop risk mitigation strategies and ensure implementation to minimize quality risks.

7. Continuous Improvement:

• Monitor quality KPIs and trends to identify improvement opportunities.
• Work with cross-functional teams to improve efficiency, reduce variability, and enhance product quality.
• Implement changes to processes, procedures, and systems as part of continuous improvement efforts.

8. Regulatory Compliance:

• Stay updated on current Good Manufacturing Practices (cGMP) and other regulatory requirements.
• Ensure the company's products and processes align with regulatory standards set by bodies like the FDA, EMA, and other national authorities.

Key Skills:

• Excellent attention to detail and analytical skills.
• Strong problem-solving abilities, particularly in CAPA and deviation management.
• Proficiency in QMS software and documentation systems.
• Effective communication and interpersonal skills for cross-functional teamwork.

Job Type: Full-time

Pay: ?200,000.00 - ?360,000.00 per year

Schedule:

• Day shift

Education:

• Bachelor's (Preferred)

Work Location: In person