QA - CSV

Responsibilities and Duties

• Preparation and review of Validation deliverables such as URS, GxP, Impact Assessment Checklist, VP, Specification documents (SDS, FRS, TS, CS), FRA, IQ Protocol & Scripts, OQ Protocol & Scripts, PQ Protocol & Scripts, DM (Data Migration) Protocol & Scripts, RTM, VSR, 21 CFR PART 11 & EU ANNEX 11 Compliance Checklist as per Webosphere CSV SOP.
• Execution/Support in the execution of IQ, OQ, PQ, and DM test scripts on the internal as well client side.
• Basic knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11, EU Annex 11, GAMP5.
• Coordinate with Client to carry out Validation activity of Computerized Systems and Software.
• Responsible for achieving & maintaining the validated status of in-scope computerized systems
• Provide guidance on CSV validation issues and discrepancies
• Support investigation of CSV defects and quality records (deviation, CAPAs).
• Ensuring systems are fully implemented and integrated with other quality management systems, site and global functions.
• Coordinating with teammates in achieving assigned tasks.
• Issue/bug tracking, and software incident management.
• Develop and execute test plans to ensure that all objectives are met.
• Implement and monitor test scripts to assess functionality, reliability, performance, and Coordinate and support to Quality Manager.
• Ensure that user expectations are met during the testing process
• Documentation adherence to internal/Client SOP and compliance.
• Managing department functional process as specified in standard operation procedure & suggest changes if required.

Qualifications

• Past experience writing, reviewing and executing computer validation documentation (URS, GxP, VP, Specification documents, FRA, IQ, OQ, PQ, RTM, VSR, 21 CFR PART 11 & EU ANNEX 11 Compliance Checklist)
• Excellent written and verbal communication skills.
• Proficiency with MS Office tools
• Documentation management
• Ability to work as a team player in a consulting environment
• Knowledge of Computer System Validation.
• Critical thinker and creative mindset and the ability to approach a problem creatively.
• A meticulous approach to work.
• A team player but can work independently too.
• Multi-tasking and time-management skills, with the ability to prioritize tasks.