Quality Assurance Validation Associate

3390 Baxalta U.S.•Thousand Oaks, CA

1d•Onsite

About The Position

As a Quality Assurance Validation Associate, you will work as part of cross-functional teams providing quality oversight, review, and approval of validation deliverables and change controls to ensure that products and processes meet appropriate regulatory agency validation requirements, internal company standards and current industry practices. This position will typically focus on disciplines related to facilities, utilities, equipment, process qualification, cleaning, QC methods and instruments, computer systems validation and data integrity.

Requirements

Bachelor’s Degree in Biotechnology, Microbiology, Pharmacy or equivalent is strongly preferred.
Minimum of 5 years of experience in Pharmaceutical, Biopharmaceutical or related manufacturing environment, or an advanced degree.
Experience in pharmaceutical/biotech validation which includes the writing and executing of protocols.
Proficiency in electronic document management systems (e.g. Veeva, Kneat, ALM)
Strong knowledge of US GMP/EU regulations and GxP guidelines.
Extensive cross-functional team experience, including technical and non-technical work.

Responsibilities

Responsible for reviewing validation documents, against Standard Operating Procedures (SOPs) for accuracy and compliance with procedures, based on regulatory requirements and internal guidelines.
Review from a quality perspective the validation documentation required to assure the proper development of a project and support regulatory submissions.
Responsible for reviewing Validation Master Plans, Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification, Computer System Validation, and Validation Maintenance packages in accordance with existing procedures.
Reviews deliverables for compliance with existing requirements.
Approves documentation related to system decommissioning.
Provide validation expertise and support for the development (or modification phases) of manufacturing facility, utilities, systems, process and information and Computerized System; address, include and implement all the applicable QA requirements.
Participate in the risk assessment related to the project.
Assure requirements traceability throughout the whole project life cycle.
Provide support in all quality-related issues, including GMP regulations
Assess and approve Change controls, CAPAs and deviations to ensure conformance to regulatory agency requirements, company standards and industry best practices
Take part in internal/external audits.
Maintain project metrics to communicate risk trends and implementation readiness to support project timelines and commercial readiness
May perform other duties as assigned.