Bioclinica India Pvt Ltd – Urgently Opening for QA – Pharmacovigilance
POSITION TITLE: QA Manager
Domain of Work: ( Pharmacovigilance /Clinical Data Management / Life Cycle Safety domain)
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 Bioclinica QA management as appropriate
Directly manage & coordinate internal and external compliance auditing programs at Bioclinica.
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.
Specialized knowledge and skills:
Quality Assurance / Quality Management space in Clinical Domain, especially in Pharmacovigilance /Data Management / Safety areas.
Sr. auditor with Gxp audit experience auditing internal & external systems.
Hands on experience and subject-matter-expertise in Clinical Data Management / Life Cycle Safety / Pharmacovigilance.
A key contributor in Driving the Organization Towards Pharmacovigilance/Data Management/Safety Regulatory Audits & Inspections.
GVP/GCP/GXP Certification, ISO, ISMS Knowledge preferred.
Education: Degree in pharmaceuticals/ Medical/life science; or Engineering degree with work experience in core Clinical Domain (Masters degree preferred)
Experience: 10+ years of relevant experience.
Desired Candidate Profile:
-Should have hands on Audit & Quality Assurance experience of minimum 8 years in Pharmacovigilance /Data Management / Safety areas.
-Experience of creating,managing SOPs & CAPA policies and procedures.
-Strong acquainted experience in GVP modules Apply online