Computerized Systems Validation BSA

This is Karthik from TRuGlobal. TRuGlobal is looking for a strong Sr.Business Analyst for a Onsite position in Alameda, Please reply back with the updated resume if you re interested with below position to

Position Details:

Title: Sr. Business Analyst -level III

Location: Alameda, CA Onsite

Type of position: 6+ Months Contract-to- Hire OR Full-time

Direct Client

General Summary:

The Sr Business Systems Analyst will assure that validated computerized systems are implemented, maintained, and obsoleted in a state of compliance. Assess the performance of regulated systems. Lead, drive and own projects and ensure effective communications and cross collaborations with the business on various Computerized Systems Validation initiatives and projects. Any communications or cross collaborations with the business are to be done by Level III and above. The Sr level will also work closely with the Manager to assist with training and mentoring more junior level CSVS and Business Analyst.

Essential Duties and Job Functions General responsibilities for this position will include (but are not limited to) the following:

Work closely with management to support other quality engineering initiatives to drive them down throughout the team.

• Work on multiple projects and meet timelines, requiring expert multitasking skills and ability to prioritize work effectively.
• Create documentation to support the design and development of solutions, such as, but not limited to, user stories, business/product requirements documents (BRD/PRD), functional and non-functional specifications and documentation (FRD), acceptance criteria, product roadmaps, and to-be process flows and traceability matrices, meeting notes, gap analysis, etc.
• Adhere to the Company s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.
• Manage and execute the deviation process during execution of testing. Author deviation form content. Work with the customer to resolve deviations recorded during test execution or system modifications.
• Apply knowledge of quality engineering principles to ensure compliance with regulatory requirements and impart that knowledge to junior level CSVS.
• Work closely with the SWQ Manager to collaborate with cross functional team to identify, prioritize and execute business critical quality initiatives.
• Ensure other members of the department follow the QMS, regulations, standards, and procedures.
• Manage conflict resolutions both transparently and proactively by continually informing manager, team, and client of progress, issues, and concerns.
• Work with end-users across the organization, to gather, understand, prioritize, and define business requirements, leveraging Medical Device, Pharmaceutical experience and best-practice methods and collaborating and seeking guidance from stakeholders.
• Provide quality support to development, engineering and manufacturing functions for design control and transfer activities.
• Facilitate and participate in internal development team s quality reviews of requirements to ensure they are complete, consistent, comprehensible, feasible, and conform to standards and align with client business objectives.
• Drive/assist the development of business strategies, as appropriate, to guide clients and inform requirements.

Position Qualifications

Minimum education and experience:

• Bachelor s degree required, in engineering, computer science, or related discipline with 12+ years related experience, preferably in the medical device, pharmaceutical, or similar FDA-regulated industry, or an equivalent combination of education and experience.
• Required to have advanced knowledge of Quality Engineering Principals and Regulatory Environment such as: 21CFR11, 21CFR820, Annex 11, ISO 13485, 21CFR210, 21CFR212, HIPAA/PHI, SOX, GDPR
• Experience with the installation, configuration, validation, and maintenance of regulated software such as Quality Management Systems, Learning Management Systems, and Clinical Trial Management Systems
• Expert knowledge of GAMP guidelines, 21 CFR Part 11, and FDA requirements and expectations for validated systems preferred.
• Strong oral, written and interpersonal communication skills.
• Strong leadership skills with ability to work effectively within a cross-functional team.
• Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously.