Assistant Quality Assurance Manager

Position Name : Assistant Manager / Manager Quality Assurance

Role Description :

Position will be responsible for QA function. Develop, implement and maintain the Quality Management System (QMS) at Scitara;

Perform audits (internal and vendor) to ensure compliance to organizational procedures, customer and regulatory requirements and establish the training function within Scitara

Key Responsibilities :

• Perform audits (internal and vendor) to ensure compliance to organizational procedures, customer and regulatory requirements
• Responsible for authoring, reviewing and approving Standard Operating Procedures, Work Instructions, Policies, Manuals and Guidance documents for Scitara
• Represent Scitara in customer audits, regulatory inspections and certification audits (ISO 27001 and SOC II Type 2)
• Responsible to ensure education and awareness about audit / inspection readiness in the organization
• Impart training on SOPs and regulations
• Manage CAPAs and deviations at an organizational level
• Ensure that software systems meet regulatory requirements (e.g., 21 CFR Part 11, EU Annex 11, GAMP 5).
• Provide QA oversight for all phases of validation (planning, testing, deployment, and change control).
• Review and approve validation deliverables (e.g., Validation Plan, Test Plan, Test Scripts, Traceability Matrix, Validation Summary Report).
• Implementing the data privacy policies and associated processes in Scitara across functional units.

Educational Qualifications : Bachelor’s or Master’s degree in appropriate field of study

Experience :

IT CSV QA candidate with 08 – 10 years’ experience in QA, IT and Computer System validation with some background of Software Development. Expertise in validation principles and validation types, software development best practices, and quality management systems used in the FDA / MHRA / EMA regulated environments is required. Preferably, candidates who have worked / supported Pharma / Life Sciences companies.

Desired Skills :

Location : Mumbai / Pune