Job Opportunities in India
September 9, 2024
Maya Biotech PVT LTD
Baddi
FULL TIME
QMS
Job Summary:
We are seeking a highly skilled and detail-oriented Quality Assurance Specialist with a focus on Quality Management Systems (QMS) to join our team. This role is crucial in ensuring the highest standards of quality and regulatory compliance within our pharmaceutical or injectables operations. The ideal candidate will possess extensive experience in managing QMS, preparing for and participating in regulatory audits, and ensuring adherence to industry standards and regulations.
Key Responsibilities:
Experience:
We are seeking a highly skilled and detail-oriented Quality Assurance Specialist with a focus on Quality Management Systems (QMS) to join our team. This role is crucial in ensuring the highest standards of quality and regulatory compliance within our pharmaceutical or injectables operations. The ideal candidate will possess extensive experience in managing QMS, preparing for and participating in regulatory audits, and ensuring adherence to industry standards and regulations.
Key Responsibilities:
- Quality Management Systems (QMS):
- Develop, implement, and maintain the QMS in accordance with industry standards, such as ISO, c GMP, 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.
- 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 c GMP, 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)
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