Are you an experienced professional in pharmaceutical quality assurance looking for a rewarding and challenging role? Cronus Pharma Specialities Pvt Ltd invites applications for the position of Assistant Manager / Senior Executive – Quality Management System (QMS). This position provides an excellent platform to leverage your expertise in QMS and play a critical role in upholding and enhancing quality standards for injectable and formulation products.
About Cronus Pharma Specialities Pvt Ltd
Cronus Pharma is a reputed pharmaceutical company committed to manufacturing high-quality injectable and formulation products. Known for its strict adherence to quality and regulatory compliance, Cronus Pharma fosters innovation and continuous improvement in its quality assurance processes. Joining the Cronus team means being part of a collaborative and dynamic environment focused on excellence.
Position Overview
- Job Title: Assistant Manager / Senior Executive – QMS
- Experience Required: 6 to 12 years
- Location: India (specific locations as per company policy)
- Qualification: Any Graduate
- Contact: +91 73374 45157
- Email: hr@cronuspharma.com
- Contact Person: Suchitra G.
This role is designed for professionals with substantial experience managing Quality Management Systems in pharmaceutical settings, especially within injectables or formulation manufacturing.
Key Responsibilities
1. Monitor and Manage the Quality Management System
You will oversee the effective implementation, maintenance, and improvement of the QMS across all departments. This includes ensuring compliance with global standards such as Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and ISO guidelines. A critical task is regularly reviewing and updating QMS documentation to keep pace with regulatory changes and internal process developments.
2. Lead Compliance Investigations and CAPA Management
Your role involves leading investigations into quality deviations, non-conformances, and product complaints. You will implement Corrective and Preventive Actions (CAPA) to address root causes, and critically evaluate CAPA effectiveness to prevent recurrence, thereby maintaining product quality and compliance.
3. Preparation and Review of Quality Documentation and Meetings
Prepare detailed reports and documentation for quality review meetings. Review and approve documentation related to technology transfers, process validations, and manufacturing changes. Maintaining accurate records is essential to support audits and regulatory inspections.
4. Manage Non-Conformances and In-Process Quality Assurance (IPQA)
Promptly escalate and manage non-conformances. Coordinate remediation and corrective actions as required. Monitor IPQA activities to ensure product quality is maintained throughout the manufacturing process.
5. Enforce Good Documentation and Manufacturing Practices
Ensure strict adherence to Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP) across the organization. Conduct training sessions to educate and update personnel on quality standards and documentation procedures.
6. Timely Closure of QMS Documents
Ensure all QMS-related documents such as CAPA reports, change controls, and deviations are closed within stipulated timelines to maintain audit readiness and operational efficiency.
7. Develop and Train on Standard Operating Procedures (SOPs)
Develop, review, and update SOPs covering various quality processes. Conduct regular training sessions to ensure staff compliance with SOPs and quality practices.
8. Prepare and Maintain Regulatory Documentation
Maintain the Site Master File (SMF) in accordance with applicable regulatory requirements. Support external and internal audits by providing timely and accurate documentation.
9. Oversee Vendor Qualification and Supplier Quality
Lead vendor qualification processes to assure the quality of raw materials, components, and services. Review vendor qualification reports and collaborate with suppliers to ensure compliance with quality standards and data integrity.
10. Implement Data Integrity Procedures
Ensure strict adherence to data integrity principles across all quality-related data. Conduct periodic reviews and audits to verify data accuracy and compliance with company and regulatory standards.
11. Audit Compliance and Continuous Improvement
Maintain audit readiness by ensuring compliance during internal and external audits. Identify areas for quality system improvement and lead corrective actions to enhance overall quality performance.
Why Choose Cronus Pharma?
- Competitive Salary Package: Attractive remuneration aligned with industry benchmarks.
- Professional Growth: Opportunities for continuous learning, training, and career advancement.
- Exposure to Global Standards: Work in an environment adhering to GMP, GLP, ISO, and other international quality standards.
- Supportive Work Culture: Join a team that fosters innovation, integrity, and teamwork.
Key Skills and Qualifications
- 6 to 12 years of proven experience in QA/QMS within pharmaceutical manufacturing, especially injectables or formulations.
- Strong knowledge of GMP, GLP, ISO, and regulatory compliance.
- Experience handling QMS documentation, CAPA, deviations, change controls, and vendor qualification.
- Excellent communication, leadership, and training skills.
- Ability to manage multiple projects and meet deadlines efficiently.
How to Apply
Interested candidates should email their updated resumes to:
Email: hr@cronuspharma.com
Phone: +91 73374 45157
Contact Person: Suchitra G.
Be sure to highlight your relevant experience in QMS and your availability.
Final Thoughts
If you are passionate about upholding pharmaceutical quality and have a proven track record in Quality Management Systems, this opportunity at Cronus Pharma Specialities Pvt Ltd is ideal for you. Join a forward-thinking company committed to excellence in pharmaceutical manufacturing and quality assurance.
Take the next step in your career by applying today and become part of a team that drives quality innovation and compliance.
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