Quality Assurance Manager
1 week ago
Job Summary: Ashish Life Science Pvt Limited is seeking a seasoned Quality Assurance Manager to lead our quality function and drive excellence in our manufacturing operations.
About Us: We are a leading pharmaceutical company committed to delivering high-quality products that meet the needs of regulated markets. Our team is passionate about ensuring compliance, customer satisfaction, and continuous improvement.
Key Responsibilities:
- Quality Leadership: Provide overall leadership to the Quality function, covering Quality Assurance, Quality Control, and Micro departments. Foster a strong quality culture and ensure audit readiness with effective change management skills.
- Audit and Compliance: Contribute to the company's aspirations to cater to regulated markets by ensuring compliance and successful audits from authorities such as EU, Australia (APVMA), US FDA (CVMA), Saudi Arabia (MSA), and others. Cover all production lines while maintaining seamless manufacturing operations.
- Manufacturing Operations: Manage, control, and sustain smooth operations of the formulation unit to meet manufacturing targets as per business requirements, adhering to cGMP, safety, and allocated budget. Ensure handling of injectable commercial products, new products, scale-up batches, and EB batches.
- Document Management: Ensure all SOPs are well-drafted inline with latest international regulations and GMP norms. Enforce adherence to SOPs at ground level, maintain governance and control mechanisms on product dispatches, and prevent recalls.
- Training and Development: Strengthen the overall QMS at the factory, provide guidance to new sites, and conduct timely reviews of vendor audits in collaboration with the purchase department. Establish new systems and drive continuous improvements through Quality-focused initiatives.
- Regulatory Affairs: Support Regulatory providing timely documents for registrations – New products as well as queries on existing products dossiers. Monitor adherence to standards and statutory compliance through periodic reviews to avoid accidents and ensure government norms compliance.
- cGMP Compliance: Ensure cGMP compliance of the unit by building, assessing, and tracking systems and controls at the unit to meet regulatory and customer requirements. Collaborate with engineering to maintain facilities and qualify equipment.
- Team Management: Must have experience in managing more than 20 quality professional team members. Ensure minimum quality complaints with appropriate CAPA submission in time and oversee the overall training program being run effectively.
Requirements: A seasoned Quality Assurance professional with a strong track record of driving quality excellence and leading cross-functional teams. Experience in managing quality compliance and successful audits for injectable lines, coupled with expertise in establishing new systems and driving continuous improvements.
Salary: ₹2,500,000 - ₹3,500,000 per annum based on location, industry standards, and qualifications. A competitive salary package including benefits, bonuses, and opportunities for growth and development.
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