Quality Assurance Lead

Job Title : Lead, Quality Assurance & Regulatory Compliance

Primary 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 Responsibilities

Maintain quality service and departmental standards by :

Contribute to team effort by :

Maintain technical and industry knowledge by :

Qualifications

Education : Bachelor’s or Master’s degree in Pharma / life sciences or equivalent in a related discipline

Experience : 6-8 years of relevant experience

Additional Skills