Quality Assurance Lead

1 day ago

Vellore, India Qinecsa Solutions Full time

Job Title: Lead, Quality Assurance & Regulatory CompliancePrimary ResponsibilitiesAssure that CRO Operations remains in compliance with corporate policies and procedures and all applicable worldwide regulations & guidelines.Deploy, Manage & improve quality management system and create awareness across the organization.Plan & roll out regulatory readiness program for eventual regulatory audits.Ensure effective execution of the readiness program.Assess the effectiveness of inspection readiness by coordinating and conducting internal and external compliance audits and applicable assessments (e.g. inspection readiness assessments).Provide consultation to operations & business enabling functions personnel on Requirements (Organization, regulatory & client) & compliance issues.Impart awareness session on applicable regulations (FDA, MHRA etc.).Lead cross-functional teams to help identify potential issues and resolve current issues.Manage compliance issues across organization and escalate issues to Qinecsa QA management as appropriate.Directly manage & coordinate internal and external compliance auditing programs at Qinecsa.Support Operations staff in the use of integrated quality systems; summarize quality reports and provide quality metrics as appropriate.Oversee CAPA management & facilitate effective corrective and preventive action (CAPA) closure.Secondary ResponsibilitiesMaintain quality service and departmental standards by:Reading, understanding, and adhering to organizational standard operating procedures (SOPs)Assisting in establishing and enforcing departmental standardsContribute to team effort by:Working with internal staff to resolve issuesExploring new opportunities to add value to organization and departmental processesHelping others to achieve resultsPerforming other duties as assignedMaintain technical and industry knowledge by:Attending and participating in applicable company-sponsored trainingQualificationsEducation : Bachelor’s or Master’s degree in Pharma/ life sciences or equivalent in a related disciplineExperience : 6-8 years of relevant experienceAdditional SkillsStrong motivational skills and abilities, promoting a team-based approachStrong interpersonal and communication skills, both verbal and written in EnglishStrong organizational and leadership skillsGoal-orientedAbility to maintain professional and positive attitude

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