Urgent Search Specialist-Quality Operation

2 days ago

Hyderabad, Telangana, India Sandoz Full time
Job Description

Major accountabilities:

- Exposure in handling of customer/market complaints, field alerts, recalls and conducting investigations. Can independently handle meetings/ discussion with business partners/ suppliers.
- Experience in creating Quality assurance agreement and Quality risk assessment for Contract manufacturers / suppliers.
- Understanding on Audits & CAPA management for suppliers.
- Strong understanding on Quality Management System and GxP requirements.
- Provide support in preparation, review and approval of GMP documents including local and global SOPs, WP s, Investigation reports, etc., where required.
- Ensure implementation of applicable Novartis QMS requirements in the function.
- Provide support as key user/ Super user for IT tools used for Quality Management System.
- Provide timely and effective communication of any potential compliance gaps/ risks in respective function, the respective SPOCs or Team Lead and facilitate for resolution of identified gaps/ risks.
- Initiate, monitor and fulfill the timely review of APQR documents for all own site and Contract manufacturers.
- Provide quality support to Nitrosamine risk-based evaluation/ Changes, as required. Initiate and implement quality improvement/ simplification projects, wherever possible. Impart trainings on GMP/Data integrity and other relevant trainings, as required.
- Create various periodic performance metrics reports for respective GxP activities and share/ present to Business leaders/ partners.
- Author technical documents (like testing plans, testing monographs, Stability report etc.) and provide data driven technical and analytical insights to improve process understanding, quality and compliance of the product.
- Manage different type of change control like product stewardship/ Administration Stewardship /Asset Stewardship in electronic system like Agile PLM, from Change Initiation to closure as needed.
- Experience in Document Management tools and competency in MS office tools.
- Ensure all time readiness of the activities for internal/ Business partner audits (including data integrity audits), host audits, and manage audit action plans for timely closure of agreed CAPAs.

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