- 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.
- 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
- 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
GxP and CSV Quality Manager - Bengaluru, India - Datafoundry
Description
Position: GxP and CSV Quality Manager
Experience Level: 5-10 Years
Location: Bangalore, Hyderabad & Vizag
About Datafoundry AI:
We're Datafoundry, a dedicated team of data scientists, life sciences experts, and technology geeks. Our mission is to help and optimize deep learning models for maximum impact. We have the expertise to help you with all aspects of the data driven business. Who we think will be a great fit? We are seeking an energetic, responsible person to join our growing organization. In this position, you will be expected to work on the data curation, preparation of datasets, and data pipeline setup. If you think you have what it takes in respect to the skills, the personality and willingness to be in a self-improving and self-challenging position with a lot of freedom and responsibility then please reach us with your CV, we would be happy to have a discussion.
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