CAW Studios
Location
Secunderabad | India
Job description
Ever dreamed of being part of new product initiatives Feel the energy and excitement to work on version 1 of a product, and bring the idea on paper to life. Do you want to work on SAAS products that can become the next Uber, Airbnb, or Flipkart We allow you to be part of a team that will be leading the development of a SAAS product.
Our organization relies on its central engineering workforce to develop and maintain a product portfolio of several different startups. Our product portfolio continuously grows as we incubate more startups, which means that different products are very likely to use different technologies, architecture & frameworks - a fun place for smart tech lovers!
We are looking for a Computerized System Validation Engineer to join one of us in Hyderabad .
Reports To: Computer System Validation Lead
Job Overview
The Computer Systems Validation Engineer is responsible for Validation activities of GxP Computer System Validation (CSV) activities in accordance with industry standards and regulatory guidance to ensure the systems are appropriately validated prior to release and remain in a compliant state throughout the lifecycle.
What will you do
· Work independently with minimal guidance on CSV projects and ensure compliance to applicable industry regulations
· Work collaboratively across functions with Quality, IT, Business partners, and Vendors to plan, coordinate, and execute CSV activities utilizing a risk-based approach
· Authoring, review CSV deliverables including but not limited to vendor assessments, change controls, system risk assessments, validation plans, user and or functional requirements specification, configuration specifications, IQ/OQ/PQ protocols, traceability matrix, summary reports and applicable SOPs (System Administration and User/Operation)
· Perform formal test executions and ensure the test results are compiled and in a timely manner
· Maintaining the validated state of supported GxP systems including periodic review and release management based on continuous cloud assurance model
· Provide Quality oversight and approval of periodic user access and audit trail reviews
· Contributes to Celito QMS software development including process definition/design, system review and development testing for functionality and User Interface (UI) as well as validation, training, and system support documentation
Who Shall Apply
· Bachelor's degree in life sciences or engineering and 7-12 years of related experience; or equivalent combination of education/training and experience
· Additionally, 5+ years of direct validation responsibilities in GxP Quality , Computer Systems Validation experience
· Experience required in performing validation of custom software systems and cloud based infrastructure.
· Working knowledge of Azure, AWS or similar PaaS.
· A strong knowledge of procedures and best practices related to FDA Regulations , 21 CFR Part 11, Computer System Validation, GAMP 5, GxP (GLP, GCP, GMP, and GVP) practices
· Ability to communicate regulations and requirements to cross functional teams.
· Experience with validation of Quality Management Systems (QMS) such as Veeva Vault, ZenQMS, or Master Control, including Electronic Document Management Systems (eDMS), Clinical Systems, Learning Management Systems (LMS), and/or Regulatory Information Management Systems is required
· Knowledge of QMS processes including: Controlled Document Management, Learning Management (Training), Deviation/Event Investigation, Corrective and Preventive Action (CAPA ), Change Control Management, and Audits and Inspections
· Able to multi-task and work cross-functionally
·Strong written and oral communication skills, able to translate complex concepts across all levels of the organization.
About CAW Studios
We are a Product Engineering Company of 200 geeks.
We run engineering for startups like Interakt, CashFlo, hBits, FastTI, Fhynix, BeTagged, FastBar, Haptik, CloudDefense, Bureau, AccelData Flipspaces, Aerchain, Freightwala, Reeco.
We are obsessed with automation, DevOps, OOPS, and SOLID. We are not into one tech stack - we are into solving problems.
Find us: CAW Studios
Website: Come, explore us!
Know More: Handbook
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