Responsibilities:  1. Should have understanding and experience in GAMP5 guidelines and 21 CFR part 11 compliance requirements.   2. Candidate should have an understanding of Process Automation activities, preferably in areas of:  - Manufacturing Execution Systems (MES)  - Laboratory Execution System (LES)  - Product Life cycle Management (PLM)  Additional experience in following areas will be desirable.  - SAP  - Lab Information Management System   - Infrastructure  3. Experience in validation deliverables in areas of hardware, software, interfaces.  4. Optimized validation approach in these.   5. Understanding of QMS events.  6. The candidate should have had experience in facing statutory and regulatory audits and closing observations, if any.  7. Additional Skills :   - Experienced in leading teams of CSV professionals and operating in cross functional groups.  - Good communication to effectively express in a 360 degree engagement.

Africa

Others

Team Lead - Quality - CSV 

Team Lead - Quality - CSV  ,Job Description for Team Lead - Quality - CSV  in Grandeur India in  Africa Others for (5-10) years of experience. Apply Now!

Job Description for Team Lead - Quality - CSV  in Grandeur India in  Africa Others for (5-10) years of experience. Apply Now!