Lead Pharmacovigilance Qa & Compliance Job in Vitrana Inc.

Description:

We are looking for an experienced Quality Assurance Lead with strong background in Computer System Validation, management of Quality Management System and audits. You will be part of Corporate Quality Assurance Group. You will be the go-to person for process clarifications related to Organization Quality Management System and will be engaged in process definition initiatives, SDLC deliverables reviews, CAPA & Deviation Management, Defect Analysis, Internal Audits, Customer Audits and qualification activities.

Responsibilities:

• Define SOPs, Validation documents and quality metrics
• Conduct Internal Audits and manage customer audits
• Coach team members on Organizational Quality Management System
• Review SDLC deliverables to ensure compliance with QMS
• Lead Process Improvement Initiatives
• Oversee CAPA implementation
• Oversee Change Request Implementation
• Perform organization level analysis for defects, incidents, CAPA, deviation
• Participate in project planning meetings, retrospective meetings, risk management meetings and project closure meetings
• Conduct Process trainings

Requirements:

• Experience: 8 to 12 years
• Proficient in Computer System Validation, Software Qualification, Software Validation, Software Implementation and Compliance
• Proficient in formulating SOPs, Validation documents, assisting / supervising audits / inspections
• Proficient in management of Quality Management System (QMS) including updates & rollouts
• Good Understanding of 21 CFRpart 11, GAMP, ISPE, ISO27001, GDPR
• Experience in CAPA management and Deviation Management
• Experience in SEPG activities like Defect analysis & baseline
• Experience in execution of Internal Audit for projects and departmental functions
• Skilled at working effectively with cross functional teams in a matrix organization
• Excellent Communication and Documentations skills
• Proficient in MS Word & Excel