Lead, Quality Assurance & Regulatory Compliance

Group Company: Qinecsa Solutions India Private Limited

Designation: Lead, Quality Assurance & Regulatory Compliance

Office Location: Bangalore (Remote Work)

Position description: 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

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.
  
  

Additional Responsibilities

• Strong motivational skills and abilities, promoting a team-based approach Strong interpersonal and communication skills, both verbal and written Strong organizational and leadership skills Goal-oriented Ability to maintain professional and positive attitude
  
  

Reporting Team

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Educational Qualifications Preferred

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Key Performance Indicators

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Work Environment Details

Specific requirements

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Other Details

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Skills Required
gvp , Gcp, Quality Management, Iso, Clinical Data Management, Quality Assurance, Pharmacovigilance