Job Profile:  - Development of DQA systems in the entire R&D to ensure QbD compliance.   - Development of desired Quality Systems across the LSI manufacturing sites as per ICH requirements.  - Implementation of Company Quality policy, Corporate Quality Audit Program & Regulatory Compliance at all sites.   - Harmonization of systems and procedures across all sites of LSI and designing systems for better documents control.  - To Facilitate Regulatory Approvals at manufacturing sites.  - Providing training on cGMP Compliances at all the manufacturing facilities.  - Keeping track by close monitoring of key quality attributes e.g. change controls, Deviations, CAPA, Investigations, Complaints, OOSs etc.  - Qualification of Toll Manufacturing sites  - Vendor Audits for Raw & Packaging Materials  - Preparation & implementation of CQA guidelines and Quality Plan  - Implementation of ISO 9001 Quality Management Systems.  - Guidance & Support on GMP & GLP issues to LSI Manufacturing sites   - LSI Manufacturing Sites: GMP audits, Gap analysis, suggestion on Corrective and preventive actions, ensuring compliance.  - Audit, review of compliance and approval of Toll manufacturing sites of LSI.   - Providing cGMP and GLP training to LSI Manufacturing sites & R&D  - Review of current regulatory guidance documents, making CQA Guidelines on key topics in line with the cGMP requirements.  - Implementation of CQA Guidelines in LSI manufacturing sites in India.  - Providing Guidance & support to down the line CQA Team  - Providing support to LSI manufacturing sites on various GMP issues.  - Audit and approval of Raw and Packaging material vendors.  - ISO 9001 Quality Management System  - ISO internal Audits of HO, R&D & Branches  - Preparation & Implementation of ISO mandatory System requirements  - Support to HO, R&D and Branches during ISO External Audits.

Delhi NCR

Head - Quality - Healthcare 

Head - Quality - Healthcare  ,Job Description for Head - Quality - Healthcare  in Tusthi Executive Access & Consultants in  Delhi NCR for (18-30) years of experience. Apply Now!

Job Description for Head - Quality - Healthcare  in Tusthi Executive Access & Consultants in  Delhi NCR for (18-30) years of experience. Apply Now!