Quality Assurance Lead

5 days ago

Malappuram, India Qinecsa Solutions Full time

Job Title: Lead, Quality Assurance & Regulatory CompliancePrimary Responsibilities- Assure 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 issues- Exploring new opportunities to add value to organization and departmental processes- Helping others to achieve results- Performing 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 Skills- Strong motivational skills and abilities, promoting a team-based approach- Strong interpersonal and communication skills, both verbal and written in English- Strong organizational and leadership skills- Goal-oriented- Ability to maintain professional and positive attitude

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