GxP and CSV Quality Manager

3 months ago

Bengaluru, India Datafoundry Full time

Position: GxP and CSV Quality Manager

Experience Level: 5-10 Years

Location: Bangalore, Hyderabad


About Datafoundry AI:


Datafoundry is an AI first company with solutions to accelerate digital transformation. As part of our initial focus on the Life Sciences industry, we have built AI-automation products in the Pharmacovigilance domain.

Datafoundry has multiple AI/ML algorithms that can solve digitalization problems across industry sectors such as Health Care, Utilities, Aerospace and Defence, Manufacturing, Banking and Financial sectors.

We are looking for a passionate individual to join our growing organization. In this role, you will work cross-functionally on risk management, computerized system validation, AI and ML validation, and the preparation and management of organizational processes. If you have the necessary skills and are willing to take on a self-improving and self-challenging position with a lot of freedom and responsibility, please reach out to us with your CV. We would be happy to discuss this with you.


Sounds interesting? Read further and Apply to join.


Key Job Role:


  • Oversee compliance to processes and standards for the SaaS solutions development, validation, delivery, and manage the review and generation Controlled Documents.
  • Manages activities to develop and perform SaaS solution assessments to identify and mitigate risks and prevent quality concerns (i.e., QIs and CAPAs).
  • Support the identification, management and prevention of risks and quality issues, and to advise, coordinate, and facilitate functioning of QMS components.
  • Provide audit support and oversee the collection and reporting of quality metrics.


Key Technical Skill:


  • High ability to work in a customer-focused, fast-paced, and agile environment with the ability to manage multiple tasks with minimum supervision
  • Expertise in computer technology quality and compliance (including Computerized System Validation, 21 CFR Part 11, Annex 11, ICH-GCP) in pharma and life science industries
  • Familiar with Software Methodologies like Waterfall, Spiral, V-Model, and Agile, and implementation of regulated systems on Cloud Platform comply with the pharma and life science regulations
  • Experience with GAMP 5 guidelines, Good Documentation Practices, Information Security Good Practices, documentation of testing and validation deliverables, and summarizing reports
  • Excellent verbal and written communication skills, business understanding, negotiation skills and strong organizational skills


Education and Training:


  • Degree level (technology, biological science, pharmacy, or other health related discipline preferred) or equivalent qualification
  • Industry recognized training i.e., Project Management, Lean Six-Sigma, auditing and/or risk management

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