Quality Assurance Validation Consultant

POSITION TITLE : Quality Assurance Validation Consultant

DURATION : Through 12 / 31 / 23 (potential for extension)

REMOTE (preference is East coast candidates due to time difference)

As a Quality Assurance Validation Consultant, CSQA, you will participate in projects delivering computer systems within the regulated areas of Pharma R&D and Vaccines.

This will be done to ensure client's R&D and Vaccines compliance and inspection readiness with respect to applicable Pharmaceutical Regulatory Agency requirements for Computerized System Validation (CSV), Electronic Records and Electronic Signatures (ERES), Data Integrity (DI) and client's controls.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following :

• Represent CSQA and participate in the review and approval of computer system documentation throughout the lifecycle of an application.
• Review and approval of change requests through to closure of computerized systems and infrastructure as applicable.
• Identify computer related business, regulatory or reputational risks associated with job responsibilities and communicate these upward along with suggestions for risk management solutions.
• Establish improvement processes, as needed, or set specific measurable targets and goals linked to CSQA / GQA / client's business needs.
• Contribute to the training, education, guidance and influencing of client's R&D staff on best quality and computer compliance policy and practices.
• Identify and mitigate computer compliance risks to client's through advice and consultancy to GQA and business units regionally and globally.
• Proactively identify, communicate, and monitor business and / or regulatory changes that could impact on quality or compliance within and across departments.
• Consult with Manager with any questions, concerns, on project related risks.
• Any other duties relevant to, and consistent with, the level of responsibility of the job, as required by CSQA management.

Why you?

Basic Qualifications :

• Demonstrable knowledge of the regulated pharmaceutical industry and computer compliance regulations and expectations
• Demonstrated hands on implementation (1-3 years) at a minimum, of one phase of the CS lifecycle of applicable industry standards in the software development lifecycle model, aligning with the Quality and Regulatory expectations for the industry.
• Communications are clear, concise, well structured, authentic and easily understood. Communicates and interacts at most levels both inside and outside of client's.
• May influence and negotiate at most levels.
• Build and maintain effective business relationships within GQA and business units.

Preferred qualifications :

Bachelor's Degree in the Life Sciences or Computer Science field, OR equivalent years’ experience, either conducting CSV or IT systems implementation.