Are you an experienced quality assurance professional seeking a challenging role in the pharmaceutical sector? Cronus Pharma Specialities Pvt Ltd is looking for a dedicated and knowledgeable QA – QMS Assistant Manager / Senior Executive to join our dynamic team. This position offers an excellent platform to leverage your expertise in Quality Management Systems (QMS) and contribute significantly to maintaining and enhancing the quality standards of our injectable and formulation products.
Position Overview
- Job Title: Assistant Manager / Senior Executive – QMS
- Experience Required: 6 to 12 years
- Contact: +91 73374 45157
- Email: hr@cronuspharma.com
- Contact Person: Suchitra G.
Key Responsibilities and Accountabilities
As a vital part of our quality assurance team, your role will encompass a wide range of responsibilities centered around monitoring, implementing, and improving the Quality Management System (QMS). Your expertise will be crucial in ensuring that all operations align with industry standards, regulatory requirements, and company policies.
Core Responsibilities
1. Monitoring and Managing the Quality Management System (QMS)
- Oversee the effective implementation and maintenance of the QMS across all departments.
- Ensure compliance with regulatory standards such as GMP, GLP, and ISO guidelines.
- Regularly review and update QMS documentation to reflect current practices and regulatory changes.
- Facilitate continuous improvement initiatives within the quality system.
2. Participation in Compliance, Investigations, and CAPA Effectiveness
- Lead investigations into quality deviations, non-conformances, and product complaints.
- Implement Corrective and Preventive Actions (CAPA) to address root causes.
- Verify the effectiveness of CAPAs to prevent recurrence and ensure product quality.
3. Preparation and Review of Quality Meetings and Documentation
- Prepare comprehensive reports for quality review meetings.
- Review and approve documentation related to technology transfers, validation, and process changes.
- Maintain accurate records to support regulatory audits and inspections.
4. Handling Non-Conformances and IPQA
- Escalate non-conformances promptly and coordinate remediation activities.
- Monitor In-Process Quality Assurance (IPQA) activities to uphold product integrity during manufacturing.
5. Ensuring Good Documentation and Manufacturing Practices
- Enforce adherence to Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP).
- Conduct regular training sessions for personnel on quality standards and documentation procedures.
6. Timely Closure of QMS Documents
- Ensure all QMS-related documents, including CAPA reports, change controls, and deviations, are closed within stipulated timelines.
7. Standard Operating Procedures (SOPs) and Training
- Develop, review, and update Standard Operating Procedures (SOPs) for various quality processes.
- Conduct training on SOPs and quality practices for staff to ensure consistent compliance.
8. Preparation and Maintenance of Regulatory Documentation
- Responsible for preparing and maintaining the Site Master File (SMF) in accordance with regulatory requirements.
- Support regulatory audits by providing accurate and timely documentation.
9. Vendor Qualification and Supplier Quality Coordination
- Oversee vendor qualification processes to ensure the quality of raw materials, components, and services.
- Review and approve vendor qualification reports.
- Collaborate with suppliers to ensure compliance with quality standards and data integrity policies.
10. Implementation of Data Integrity Procedures
- Ensure strict adherence to data integrity principles across all quality data.
- Conduct periodic reviews and audits to verify data accuracy and compliance.
Audit Compliance and Continuous Improvement
Maintaining audit readiness is a key aspect of this role. You will be responsible for ensuring compliance during internal and external audits, identifying areas for improvement, and implementing corrective actions to enhance overall quality systems.
Why Join Cronus Pharma Specialities Pvt Ltd?
At Cronus Pharma, we are committed to delivering high-quality pharmaceutical products by adhering to the highest standards of quality assurance. Joining our team means being part of a forward-thinking organization that values innovation, integrity, and excellence.
Key Qualifications and Skills
- Proven experience (6-12 years) in QA/QMS within the pharmaceutical industry, especially in injectables or formulations.
- Strong knowledge of GMP, GLP, ISO standards, and regulatory requirements.
- Experience in handling QMS documentation, CAPA, deviations, and change controls.
- Familiarity with vendor qualification and supplier quality management.
- Excellent communication, leadership, and training skills.
- Ability to manage multiple projects and meet strict deadlines.
Key Benefits
- Competitive salary package.
- Opportunity for professional growth and development.
- Exposure to international quality standards.
- Collaborative and supportive work environment.
How to Apply
Interested candidates can reach out for further queries or to submit their application:
- Email: hr@cronuspharma.com
- Phone: +91 73374 45157
- Contact Person: Suchitra G.
Join Cronus Pharma Specialities Pvt Ltd and become a part of a dedicated team committed to excellence in pharmaceutical manufacturing and quality assurance.
Final Note
If you are passionate about maintaining the highest quality standards in pharmaceuticals and have a proven track record in QMS management, this is the perfect opportunity for you. We look forward to your application and the possibility of welcoming you to our esteemed organization.
