quality validation expert in chennai

posted
contact
randstad india
position type
temporary
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posted
location
chennai, tamil nadu
function
Other
position type
temporary
experience
3
reference number
55405
contact
randstad india

job description

quality validation expert in chennai

> 1. Identifying, Planning and implementation of validation requirements ina cGMP Environment, including cleanroom, equipment, instruments andmanufacturing/testing processes, in a Green Field Pharma facility>> 2. Conversant with QC lab test methods like Glycerine penetrometer,Endotoxin (LAL), flow/delta p,and oxidizable substances testing.>> 3. Fully conversant with environmental testing in a clean room.>> 4. Conversant with Risk management techniques.>> 5. Experienced in Microbiology techniques.>> 6. Ensuring the laboratory's Quality Management Systems (QMS) conformswith requirements in the ISO 9001 standard, applicable Merck Group policies,Merck Life Science policies and procedures, and laboratory Quality documents,>> 7. Developing quality objectives that are compatible with the context andstrategic direction of the organization, and for communicating these qualityobjectives as well as the Quality Policy to all within the organization>> 8. Proactively identifying risks and opportunities through a variety ofsurveillance activities including trending of non-conformance events, labwalkthroughs, self-inspections and lab records/data review ensure continuedsuitability, adequacy, effectiveness and alignment of the QMS with thestrategic direction of the organization>> 9. Communicating and reviewing risks with site and global management toensure customer, statutory and regulatory requirements are determined,understood and consistently met>> 10. Supporting and actively participating in the local implementation ofglobal projects or initiatives, change management related to new and revisedservices, and communication customer notifications as needed>> 11. Supporting EHS and OSHA implementation as needed.>> 12. Staying current with standards and procedures, applicable industryregulations and trends.>> 13. Shall be a Global team player willing to embrace multiculturalism,multilingual and multi-time zone work environments.>> 14. Have Excellent networking skills allowing effective interactions andthe ability to work collaboratively across all functions with various levelsof stakeholders>> 15. Have Proven experience with various problem-solving methodologies>> 16. Have ability to manage change and implement improvement solutionsacross cross- functional team>>

skills

quality