Specialist - Quality Operations (GQS I) Sandoz India Pvt Ltd

0.0 years

0 Lacs

Mumbai, Maharashtra, India

On-site

Major Accountabilities Process / Send technical complaints to CMO / Supplier for investigation. Co-ordinate for complaint sample availability, additional information from Country Organization (CO) to CMO (Contract Manufacturing Organization) and vice versa as and when required. Periodic follow of complaints with supplier for timely investigation. Perform queries in QMS tools like GxQEM as per the procedures. Reviewing of supplier investigations and completing it in QMS tool for complaints delegated to GQSI. Perform the role of QA approver for complaints delegated to GQSI. Tracking and extension of complaint / actions as per the requirements. Complete the assigned tasks as per business need. Management of Child records such as Investigation, Communication action etc. as per the requirement. Participate in meetings / discussions between sites and suppliers over supplier complaints as and when required. Perform Quarterly complaint/ deviation trending and reporting. Evaluation of Signals and further management in QMS tool. Why Sandoz Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more! With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably. Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged! The future is ours to shape! Show more Show less

Posted 1 week ago

Apply

Management Representative- AS9100 Triveni Hi-tech

10.0 - 12.0 years

11 - 12 Lacs

Tumkur, Bengaluru

Work from Office

Job Description Triveni Hi- Tech Private Limited is looking for an experienced QMS Manager / Management Representative (MR) to lead and manage our Quality Management System (QMS) as per AS9100 standards. The ideal candidate will ensure compliance, continuous improvement, and maintain high-quality standards as per Aerospace Industry requirements. Responsibilities: Oversee and uphold the Quality Management System (QMS) in accordance with AS9100 and customer specifications. Serve as the Management Representative (MR) during customer, third-party, and certification audits. Perform internal audits, detect non-conformities, and facilitate corrective and preventive actions (CAPA). Document the minutes of the Management Review Committee meeting for future reporting on the performance and enhancement of the Quality Management System. Address customer complaints, conduct root cause analysis (RCA), and execute preventive measures. Review and manage QMS documentation, including SOPs, Work Instructions, control plans, PFMEA, etc. Implement training programs for employees regarding QMS and process enhancements. Track and report on QMS performance using KPIs and communicate findings to senior management. Collaborate with cross-functional teams, including production, purchasing, design, and engineering, to improve processes. Lead continuous improvement initiatives aimed at optimizing processes and minimizing waste. Ensure awareness of customer requirements throughout the organization. Key Requirements Bachelors Degree in Engineering (Mechanical/Production/Industrial preferred). 10-15 years of relevant experience in QMS/quality systems roles in aerospace/defense/precision component manufacturing . In-depth knowledge of AS9100,, QMS tools, and compliance standards. Excellent communication, documentation, reporting, and leadership skills. ERP, QMS software, and MS Office proficiency. Knowledge of CNC/VMC operations, GD&T, and NADCAP (preferred). Role & responsibilities Preferred candidate profile

Posted 1 month ago

Apply

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.