Designation: Validation Lead
Minimum degree requirement is a Bachelor’s in Pharmaceutical Sciences or Chemistry
- Develop validation and quality assurance documents including templates for validation related documentation such as Validation Protocols, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
- Review Risk Assessment Documentation to check the areas with deficiency, reviewed Corrective and Preventive Action (CAPA) and drafting Remediation Plans for the project management approval after the GAP Analysis
- Develop detailed Project Plan, reviewed User Requirement Specifications (URS) and Functional Requirements Specifications (FRS)
- Develop Test Plan, Test Cases, Test Script, and Test Result Report for Manual as well as Automatic Testing
- Documentation of various stages of validation lifecycle, in accordance with FDA 21 CFR Part 11 and 820 regulation.
- Develops and approves quality system documentation such as standard operating procedures and work
- Follows all Quality System requirements and company procedures ensuring regulatory requirements are met in an ethical manner.
- Supports, leads in the development and executes process validation protocols, FMEAs, quality plans, inspections (control) plans and specifications.
- Provide technical quality support and documentation for pilot production, validation and verification builds.
- Participate in and lead, when assigned, process improvement teams working with cross functional team members to meet business objectives.
- Prepare Validation Master Plans (VMP) for validating analytical laboratory equipment
- Work on validation for lab equipment including GC, HPLC, Spectrophotometer (FT-IR, MS, UV-Vis), Autoclaves, Ovens, Incubators, labeling systems, Calibration software (preferably Maximo), Freeze dryer systems in compliance with standard guidelines and regulations
- Play a major role in performing Part 11 assessment, especially contributing to the components involved in maintenance of Electronic Records (ER), Electronic Signatures (ES) and Audit Trails in accordance with 21 CFR Part 11 regulations
- Assist to ensure audit readiness of the validated systems
- Assist in activities and tasks required to complete qualification and validation activities including reviews with Quality, obtaining signature approvals, executing qualification protocol or validation project plan, managing change control and remediation
- Support risk assessment and system lifecycle processes such as change control and document management
- Contribute to systems validation in a regulatory environment, including systems, but not limited to process automation, enterprise systems, laboratory systems, spreadsheets, management dashboards, or quality systems
- Proactively escalated issues and risks appropriately through proper channels
- Involve in deficiency investigations, reviewing and preparing SOPs and quality system development
- Design and write training manual template and were involved in project planning.