Computer System Validation (CSV) & Compliance Specialist

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Job Location

Mason

 

Job Description

 

Responsible for standardization of technology and information systems supporting Quality and Quality Assurance. Recognized as global system and technology experts, supporting Quality Management with optimization of quality, value, time, resources and minimizing risks to compliance or quality. Leads Computer System QA activities including review and approval of computer system validation plans and reports, changes control of computer systems and other related activities. Drives continuous improvement through harmonization of site quality systems and technical services using appropriate process improvement and problem solving techniques.

 

Job Qualifications

 

Qualifications:

 

Basic Qualifications

    * BS or MS in Science or Information Technology related field is desired

    * Familiarity with laboratory based instrumentation and software validation is desired

    * Experience working in a regulated laboratory or manufacturing environment is desired

 

Preferred Qualifications

    * Experience required in GMP or other related regulation and/or computer system validation of manufacturing and laboratory systems – Familiarity with the application of FDA 21 CFR Part 11, EU Annex 11, and/or Data Integrity mentorship highly desired. 

    * Knowledge of and practical experience in the concepts of CSV – Familiarity with system development life cycle (SDLC), requirements analysis, software testing, release and change management is highly desired and would be an asset. Familiarity with laboratory-based instrumentation and software validation is desired.

    * Ability to engage and influence others in enabling efforts to continuously improve results.

    * Skilled in simplifying and improving work processes in a cycle of continuous improvement. Ability to understand sophisticated processes including digital and/or system infrastructures and identify areas for possible improvement (efficiency and risk reduction) within your area of responsibility, propose options and gain alignment from collaborators. Implement your ideas once aligned.

    * Ability to develop a plan, focus on priorities, lead timelines, initiate action, and implement with both agility and purpose. 

    * Excellent written and oral communication skills; Shown strength in presenting sophisticated issues in writing that promotes understanding and a framework for partnership and objective engagement on solution development.

 

In addition

 

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, disability status, age, sexual orientation, gender identity and expression, marital status, citizenship, HIV/AIDS status or any other legally protected factor.

 

Immigration sponsorship is not available for this role. As a general matter, Procter & Gamble does not sponsor candidates for nonimmigrant visas or permanent residency. However, Procter & Gamble may make exceptions on a discretionary basis. Any exceptions would be based on the Company's specific business needs at the time and place of recruitment as well as the particular qualifications of the individual.

 

Procter & Gamble participates in e-verify as required by law.

 

Qualified individuals will not be disadvantaged based on being unemployed.

 

Job Schedule

Full time

 

Job Number

R000067838

 

Job Segmentation

Recent Grads/Entry Level (Job Segmentation)