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Position: QA - CSV - Serialization

Duration: Open (Long Term)

Job Description:

The Contractor, Quality Assurance Computer System Validation (CSV) supports the on-going enhancement of Client's computer systems related to GxP functions by leading and/or providing the Quality oversight required to ensure regulatory compliance. This involves working with cross-functional internal and external resources, both domestically and internationally, to support corporate quality objectives involving GxP-related computer systems and to ensure compliance and quality in a regulated environment.

The incumbent works cross-functionally with internal departments and external resources on Quality-related issues.

This position supports adherence to relevant regulatory requirements, the Quality Management System (QMS) and company Standard Operating Procedures (SOPs) as appropriate.

ESSENTIAL FUNCTIONS:

Primary duties/responsibilities:

• Writes and/or reviews and approves CSV documents. This includes, but may not be limited to, Validation Plans, Functional Risk Assessments, Application Design or Configuration Specifications, applicable Test Scripts or other documents as may be appropriate.
• Acts as the Quality contact and Subject Matter Expert (SME) for activities related to validation and Quality Risk Management for assigned GxP computer systems.
• Assists and/or performs quality reviews and Quality Assurance (QA) vendor audits related to computer systems.
• May assist in the management and/or oversight of other external resources for CSV-related activities.
• Reviews system master plan for alignment with corporate requirements.
• Performs GxP-related activities in alignment with business requirements and ensures that they meet compliance standards as defined by the applicable regulations.
• Ensures evolving validation requirements are appropriately applied to Client's CSV activities.
• May write, contribute to or edit, as appropriate, SOPs related to the validation of GxP computer systems and/or the use or administration of the validated system(s).
• May assist in the development of training materials, related to the validation of GxP computer systems and/or the use or administration of validated systems. Works closely with IT and software/system vendor(s) as needed, to ensure user/design materials and test documentation can be leveraged and is acceptable.
• Applies knowledge of Cloud-based, SaaS systems, thoroughly interprets CSV regulations, guidelines and GxP practices and meets regulatory compliance and corporate business requirements.
• Liaises with IT and other cross-functional business teams in the development of GxP/Non-GxP deliverables, SOPs, Work Instructions, Policies and other critical documentation.

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

• Describe the following criteria, which are necessary to effectively perform the position:

* Minimum level of education and years of relevant work experience.

• Bachelor's degree in technical, scientific or other relevant academic discipline and a minimum of 6 years of experience in a pharmaceutical, biotechnology or related environment combined with a minimum of 3 years of experience in GxP Computer System validation or equivalent experience and/or education.

* Special knowledge or skills needed and/or licenses or certificates required.

• Demonstrated, hands-on, applied knowledge and understanding of applicable GxP or other relevant regulatory authority regulations and guidances related to CSV (such as, GMP, GAMP, Part 11, Annex 11, ICH Q9, etc.) activities and compliance.
• In-depth knowledge of relevant CFR (Title 21), Food and Drug Administration (FDA) and International Conference on Harmonization (ICH) guidelines including thorough knowledge of appropriate GCP, GLP, and GMP policies and procedures.
• Demonstrated ability to lead and perform computer system validation activities.
• Ability to influence without direct authority.
• Proficiency with Microsoft Office and Project Management Tools.
• Excellent verbal and written communication and skills.
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.

*Special knowledge or skills and/or licenses or certificates preferred.

• Experience with EDMS (Electronic Data Management Systems), Veeva Vault and/or ComplianceWire.
• Experience with Serialization/Tracelink

* Travel requirements

• 5-10%