• Citizen

• Full Time

• Direct Hire

• UG :- - Not Required

• PG :- - Not Required

• No of position :- ( 1 )

• Post :- 26th Jul 2022

About the role:

• Identifying, Planning and implementation of validation requirements in a cGMP Environment, including cleanroom, equipment, instruments and manufacturing/testing processes, in a Green Field Pharma facility, Shall have experience in validation as per ISPE CQ guidelines

• Should have experience in managing team
• Conversant with QC lab test methods like filter integrity testing, Endotoxin (LAL), flow/delta and oxidizable substances' testing
• Have expertise in environmental monitoring, water monitoring in cleanroom and have ability to trouble shoot the excursions
• Have experience in organism identification activities
• Have expertise in trending EM results and RCA /CA
• Conversant with Risk Management techniques
• Experienced in Microbiology techniques
• Have expertise in handling shelf life studies (accelerated and routine)
• Have experience in building quality related infrastructure, instruments including preparation of URS, System Risk Assessment, and subsequent validation
• Have experience in running AHU, trouble shooting
• Conversant with cleanroom design
• Ensuring the laboratory's Quality Management Systems (QMS) conforms with requirements in the ISO 9001 standard, applicable Merck Group policies, Merck Life Science policies and procedures, and laboratory Quality documents
• Developing quality objectives that are compatible with the context and strategic direction of the organization, and for presenting these quality objectives as well as the Quality Policy to all within the organization
• Proactively identifying risks and opportunities through a variety of surveillance activities including trending of non-conformance events, lab walkthroughs, self-inspections and lab records/data review ensure continued suitability, adequacy, effectiveness and alignment of the QMS with the strategic direction of the organization
• Presenting and reviewing risks with site and global management to ensure customer, statutory and regulatory requirements are determined, understood and consistently met
• Supporting and actively participating in the local implementation of global projects or initiatives, organizational change related to new and revised services, and communication customer notifications as needed
• Supporting EHS and OSHA implementation as needed
• Staying current with standards and procedures, applicable industry regulations and trends
• Shall be a Global standout colleague willing to accept multi-cultural, multi-lingual and multi-time zone work environment
• Have Excellent networking skills allowing effective interactions and the ability to work collaboratively across all functions with various levels of collaborators
• Have Proven experience with various problem-solving methodologies
• Have ability to lead change and implement improvement solutions across cross- functional teams

Who you are:

• You have proven experience of 12 years into validation working for a big MNC pharma/healthcare company
• Education - M.Sc/M.Pharm/M.Tech