Quality Validation Specialist || Hybrid || Raleigh, NC
About The Position
The Quality Validation Specialist supports planning and adherence to qualification and validation plans for the commercial product pipeline and the transfer of INDV-6001 to Indivior FCP and US finished product facilities for Phase III and commercial production. The role generates and manages Indivior QMS records required to transfer products to new facilities, including change controls, risk assessments, CAPA, and qualification and validation protocols and reports. The specialist technically interprets, writes, and reviews controlled documents and reports; reviews data generated by others; and participates in quality operational investigations. The role approves commercial product validation protocols and reports, executes validation-project change-control tasks, and provides validation planning and execution surge support for Raleigh. The role coordinates and communicates the move, technology transfer, qualification, and validation of INDV-6001 API and drug product manufacturing processes to Indivior FCP and Curia Burlington. It tracks and escalates delays in technology-transfer activities to FCP and US finished-product manufacturing sites, and completes documentation related to the move, transfer, testing, qualification, and validation. Additional support may include commercial lifecycle validation and Raleigh site validation projects.
Requirements
- Bachelor's degree in Life Sciences or Engineering.
- 3 to 5 years of experience in regulated GMP manufacturing, or equivalent understanding of applicable regulatory requirements.
- GMP documentation writing and review experience.
- Knowledge of the pharmaceutical industry and Quality Systems, or experience within a GxP discipline such as GPV, GCLP, GMP, or GDP.
- Proficiency in validation and qualification, including risk assessments for equipment, facilities, and processes.
- Knowledge of EU Annex 15 validation and qualification requirements.
- Ability to work in a team and cross-functionally.
- Good written and oral communication skills.
- Ability to develop influence in areas without direct reporting authority.
- Ability to work independently and deliver outputs through others as required.
- Attention to detail.
- Adept IT skills and ability to learn quickly.
- Proficiency in English.
Nice To Haves
- Extensive knowledge of aseptic manufacturing requirements and procedures for drug products, as applicable to the position's focus.
- Extensive exposure to a cGMP environment.
- Knowledge of technology transfer and process validation requirements.
- Knowledge of drug-product regulatory requirements, including FDA, EMEA, Health Canada, and other markets.
- Fluency in other languages.
Responsibilities
- Support planning and adherence to qualification and validation plans for the commercial product pipeline and INDV-6001 transfer.
- Generate and manage Indivior QMS records, including change controls, risk assessments, CAPA, and qualification and validation protocols and reports.
- Technically interpret, write, and review controlled documents and reports, and review data produced by others.
- Participate in quality operational investigations.
- Approve commercial product validation protocols and reports throughout the commercial product validation lifecycle.
- Execute change-control tasks for validation projects.
- Provide validation planning and execution surge support for Raleigh.
- Execute and review QMS records, deviations, change controls, and CAPA for Indivior portfolio validation projects.
- Coordinate and communicate the move, technology transfer, qualification, and validation of INDV-6001 API and drug product manufacturing processes to Indivior FCP and Curia Burlington.
- Track and raise awareness of delays in technology-transfer activities to FCP and US finished-product manufacturing sites.
- Complete documentation related to the move, technical transfer, testing, qualification, and validation.
- Review technical-transfer plans, test plans, change controls, qualification documents, and validation documents for adherence to EU Annex 15 and 21 CFR Part 211.
- Ensure facilities and utilities are qualified and validated at FCP and US finished-product manufacturing sites.
- Support development and closeout of technology-transfer protocols and reports, change controls, and qualification and validation protocols and reports.
- Participate in third-party validation planning meetings and communicate key information to Indivior stakeholders.
- Support other validation projects as needed, including commercial lifecycle validation and Raleigh site validations.
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What This Job Offers
Career Level
Mid Level
