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|Company Name*:||Zeon Lifesciences Ltd|
Sector 65, Noida Noida
|Contact Person*:||Amit Ranjan|
|Job Department*:||Quality Assurance|
|Job Title*:||Manager- Corporate Quality Assurance|
|Required in*:||Formulation Unit|
|Job Responsibilities*:||Leading Corporate Quality Management system, support Plant QA to strengthen & ensure that all Quality systems maintained as per regulatory compliance to fulfill the need of regulatory / Client audits. |
To be responsible and accountable for all activities related to QMS of Corporate Quality Assurance, across the plants, its subsidiaries and associates including projects. His responsibilities also includes, standard designing, implementing and monitoring of systems.
Perform critical review of all associated raw data (from R&D as well as Manufacturing) already reviewed/ approved by CQA/QA/QC/ Analytical data reviewers (As applicable) and ensure the accuracy, completeness and integrity of data/document supporting regulatory.
Reviewing and approving validation and qualification documents.
Imparting the training to all the concern personnel for effective implementation of QMS.
Reviewing and approving all the NCRs, Deviation's, Change Controls pertaining to the facility.
Experience in QA/ IPQA activities for the formulations business
Vendor/ Supplier evaluation
Ensure GMP/ cGMP compliance
Experience of Regulatory matters
Handle Change control, incidents, CAPA
Support regulatory audits
Investigation of root causes and implementation of corrective and preventive actions. Handling of Deviations, Non-conformances, Out of Specification, Change Controls and CAPA Tracking.
Exposure of market complaint, batch failure investigations.
Handled regulatory Audits, observations & its compliance Management.
Review and update the quality matrices and audit compliance status and presenting to senior management review board.
Ready to travel to vendor locations / Plant.
|Audit Experiance:||USFDA, MHRA|
|Salary Per Annum:||7-12 LPA|
|Additional Details:||Zeon Lifesciences Limited|
Zeon is a research oriented, reliable third party/contract manufacturer that provides products to a large number of world-class health & wellness organizations. Founded in 1987, Zeon is committed to deliver superior quality Nutraceutical & Ayurvedic products that are created using modern techniques of science and infrastructure. In an effort to meet the growing consumer demands, we, at Zeon, are continuously working towards modernization of our facilities in order to provide the highest quality of finished and semi-finished products.
|Note:||Please send your resume to above email address to apply this job.|
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