Implementation and Management of Quality Assurance processes and ensuring compliance across the organization including, but not limited to, operational, regulatory and IT Domains. The role will also be responsible for supporting training and audits/inspections
Support ongoing compliance with quality and industry regulatory requirements.
Provide support during continuous process improvements.
Continuously work with internal and external stakeholders to ensure compliance with agreements, applicable regulations, and guidelines.
Ensure compliance with the assigned projects including, but not limited to, operational, regulatory and IT Domains. The role will also be responsible for supporting training and audits/inspections.
Management of quality, compliance and documentation across assigned projects.
Support department/function during audit/inspection.
Identify new training and development requirements relevant to the functions.
Respond to/represent department/ function during audits and inspections, as needed.
Have ownership of assigned projects and tasks to ensure adherence to timelines and quality standards.
Train and mentor personnel, as needed.
Author and review SOPs and other documents relevant for department/ function, as needed.
Required Skills/Experience
More than 6 years of QA experience.
Experience in team management, training and mentoring personnel.
Knowledge of regulatory requirements of key regulatory authorities.
Ability to work independently with minimal supervision.
Strong communication and time management skills.
Educational Requirements
Graduate, Postgraduate, 4-years college degree or equivalent, in a scientific or health care discipline
Recommended Keywords
GVP, Audits and Inspection, CSV, GAMP, Deviation Management, Change Control, RCA, Team Management, cross functional coordination
