|Reference # : ||19-00288
||Title : ||QA Validation Specialist|
|Experience Level : ||
||Start Date / End Date : ||06/03/2019 / 12/29/2019
| Description |
|The Quality Assurance Validation Specialist will 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
Performs other duties as assigned.
Experience: A minimum of 2-5 years of experience in the pharmaceutical and/or biological validation field
Strong organizational, time management, and project management skills, with exceptional attention to detail
Works effectively in a team environment, with excellent reasoning and negotiating skills
Results oriented and ability to meet firm deadlines while working in a complex and variable environment
Requires knowledge of the current GMPs and USDA requirements
Requires critical and analytical thinking skills along with ability to make some independent decisions
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
Manual dexterity and visual acuity are important
Must be able to wear appropriate Personal Protective Equipment (PPE)
Requires critical and analytical thinking skills
Proficient with Microsoft Office software and other database software
Excellent oral and written communication skills
Requires frequent walking, stooping, bending and standing for extended periods of time and some lifting.
Prior experience in sterile filling technology and accessory equipment (Autoclaves, Dry Heat Ovens, Filler, Capper, and Control Rate Freezers) a plus