- Title: QA Validation Specialist
- Code: RCI-BI-9192704
- Location: Gainesville Georgia (GA) 30501
- Posted Date: 05/16/2019
- Duration: 6 Months
- Status: Open
- Email: Ankit.Shah@rangam.com
- Phone: 908-704-8843 ✖ 210
Ensure that requirements for initial or on-going qualification/ validation for premises, equipment and information systems (PEIS) are documented to allow life-cycle traceability in accordance with cGMP practice. As a member of Quality Assurance function the specialist ensures Validation Master Plans are developed, updated, audited and executed.
The Specialist will function as part of the Industrial Operations manufacturing and/ or project core teams. As a representative of the Quality Assurance department, the Specialist shall perform the required activities below:
- Perform criticality analysis for initial or on-going validation/qualification based on the Global Quality standards and regulatory requirements
- Develop and document the process and project Validation Master Plans (VMPs)
- Plan and structure validation activities for facilities and equipment in coordination with engineering project management and/ or manufacturing management
- Attend and monitor execution of factory acceptance testing at supplier’s site when necessary
- Ensure that the validation activities identified in the VMP are implemented and documented through protocols for design, installation, operational, software and performance qualifications
- Develop a project validation summary report at the end of the project based on validation reporting template requirements
- Hands-on Process Validation Master Plan support, develop validation protocols, review and audit protocols, update the VMP’s, in collaboration with manufacturing teams
- Perform and assist with the execution of validation activities
- Responsible for hands-on training and development of manufacturing capability in execution of validation
- As Lead role, maintain and report environmental monitoring results to QA and site senior management and also to facility owners. Develop and report metrics as needed.
- As Lead role, ensure all manufacturing sites water systems are compliant with Global Quality standards.
- Adhere to all HSE guidelines and regulations
- In addition to the above, other assigned duties & projects deemed appropriate within the position scope
experience in the pharmaceutical and/or biological validation field
- Requires knowledge of the current GMPs and USDA requirements
- Requires frequent walking, stooping, bending, twisting, turning, and standing for extended periods of time and some lifting, pulling or pushing up to 50 lbs.
- Must be able to stand for extended periods of time and work in a sterile production environment
- Must be able to wear appropriate Personal Protective Equipment (PPE)
- Proficient with Microsoft Office software and other database software
- Requires frequent walking, stooping, bending and standing for extended periods of time and some lifting.