DHF Remediation-Medical Devices-Technical Lead

Roles & ResponsibilitiesConduct DHF Gap Assessments: Review existing DHFs to identify discrepancies, missing information, and non-compliance issues with current regulations.Develop Remediation Plans: Create detailed action plans to address identified gaps, including corrective actions (CA) and preventive actions (PA).Implement Remediation Activities: Execute...

Looking for Immediate joiners - From 3+ to 10 yrs :- Key responsibilities Validation Gap Analysis: Conduct comprehensive gap analyses of existing IQ, OQ, and PQ documentation, protocols, and processes against regulatory requirements (e.G., FDA 21 CFR Part 820, ISO 13485) and industry best practices. Deviation Investigation and Resolution: Investigate...

Looking for Immediate joiners - From 3+ to 10 yrs :- Key responsibilities Validation Gap Analysis : Conduct comprehensive gap analyses of existing IQ, OQ, and PQ documentation, protocols, and processes against regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485) and industry best practices. Deviation Investigation and Resolution : Investigate...

Looking for Immediate joiners - From 3+ to 10 yrs :-Key responsibilities Validation Gap Analysis: Conduct comprehensive gap analyses of existing IQ, OQ, and PQ documentation, protocols, and processes against regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485) and industry best practices. Deviation Investigation and Resolution: Investigate...

Looking for Immediate joiners - From 3+ to 10 yrs :-Key responsibilitiesValidation Gap Analysis: Conduct comprehensive gap analyses of existing IQ, OQ, and PQ documentation, protocols, and processes against regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485) and industry best practices.Deviation Investigation and Resolution: Investigate deviations...

Looking for Immediate joiners - From 3+ to 10 yrs :-Key responsibilitiesValidation Gap Analysis: Conduct comprehensive gap analyses of existing IQ, OQ, and PQ documentation, protocols, and processes against regulatory requirements (e.G., FDA 21 CFR Part 820, ISO 13485) and industry best practices.Deviation Investigation and Resolution: Investigate deviations...

Looking for Immediate joiners - From 3+ to 10 yrs :-Key responsibilitiesValidation Gap Analysis: Conduct comprehensive gap analyses of existing IQ, OQ, and PQ documentation, protocols, and processes against regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485) and industry best practices.Deviation Investigation and Resolution: Investigate deviations...

Looking for Immediate joiners - From 3+ to 10 yrs :-Key responsibilitiesValidation Gap Analysis: Conduct comprehensive gap analyses of existing IQ, OQ, and PQ documentation, protocols, and processes against regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485) and industry best practices.Deviation Investigation and Resolution: Investigate deviations...

Looking for Immediate joiners - From 3+ to 10 yrs :-Key responsibilitiesValidation Gap Analysis: Conduct comprehensive gap analyses of existing IQ, OQ, and PQ documentation, protocols, and processes against regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485) and industry best practices.Deviation Investigation and Resolution: Investigate deviations...

Looking for Immediate joiners - From 3+ to 10 yrs :- Key responsibilities - Validation Gap Analysis: Conduct comprehensive gap analyses of existing IQ, OQ, and PQ documentation, protocols, and processes against regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485) and industry best practices. - Deviation Investigation and Resolution: Investigate...