QA Validation Specialist

Job Description

One of our large pharmaceutical clients is hiring for a QA Validation Specialist to join their team in Malvern PA. This individual will support the Clinical Manufacturing Organization at the Malvern site.

Responsibilities will include:

-Provide overall Quality Validation support of the clinical manufacturing facility inclusive of manufacturing and in process testing laboratory.

-Oversee and perform quality approval of Analytical Instrument Qualification (AIQ) and Risk Based C&Q activities following procedures. Performing Equipment Releases for equipment and instruments per local procedures.

-Will perform the following duties but not limited to: Review and Approval of CMMS Change Controls, Work Order Cancelation/Deferment Forms and Validation Forms.

-Work on a team for quality responsible for instruments undergoing AIQ, C&Q, and review and approve associated documentation.

-Complete equipment/instrument lifecycle management forms. Complete required release paperwork.

• Perform quality review/approval of assessments, protocols, final reports, and standard operating procedures as required.

-Support activities associated with project execution during routine shutdowns for upgrades and preventative maintenance.

-All activities will be executed under the direction Quality Validation personnel.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [email protected] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy:

Skills and Requirements

-Minimum 5 Years of GMP experience in the validation realm

-Strong understanding of qualification principles, executing qualification actitvies

• Knowledge of Equipment Lifecycle Management Process

• Validation/Qualification of GxP Lab Equipment and Process Equipment

• Review and approval of Standard Operating Procedures

-Computer System Validation and Data Integrity

-Change Management Process

-Navigating and recording documentation in electronic systems per Good Documentation Practices -Document Management Systems

-Change Control systems (such as Salesforce)

-SAP

-DeltaV, EMS, BMS, Green Button Go