Job Description

Job Description

E-CQR Inc. is a Texas based company and offers a broad range of business solutions and technology services to help clients in achieving their business goals. Our top notch consultants are providing services to industry's top Pharmaceutical, Biotechnology, Medical device, Clinical research, Diagnostics, Chemical, Bio Medical, Drug development, Bioinformatics and Therapeutics companies.

As a Computer Systems Validation Engineer , you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world.

• Implementing risk-based validation approach to ensure IT (GxP) software and applications comply with regulations and industry guidelines
• Developing and executing software validation projects to meet validation deliverables
• Facilitating the resolution of key quality validation issues by assisting in failure investigations, assisting in problem resolution, and providing feedback to IT development and infrastructure teams.
• Interpreting the quality requirements including verification/validation planning, execution, and problem resolution.
• Supporting audits as a technical subject matter expert for software and application validation. Supports audits performed governmental competent authorities (e.g., US Food and Drug Administration (FDA) inspections), Notified Body audits, and internal/corporate audits.
• Reviews and approves updates to quality system and IT validation documents.
• Interacting frequently with Quality, Information Technology, Manufacturing, R&D Validation and Verification laboratory and other business units to support project and objective completion.
• Participates in any and all reasonable work activities as may be deemed suitable and assigned by management.
• Conforms to, supports, and enforces all Company policies and procedures.

Your Skills And Expertise :

• Bachelor's degree or higher in a Science or Engineering (computer science, mechanical engineer, chemical engineer, industrial engineer, or engineering Science) discipline completed and verified prior to start
• Three (3) years experience in computer system validation for medical device industry

Additional qualifications that could help you succeed even further in this role include:

• Master's degree or higher in a Science or Engineering (mechanical engineer, chemical engineer, industrial engineer, or engineering Science) discipline from an accredited institution
• Quality Systems experience (CAPA, non-conformances, deviations, etc) and/or software validation experience
• Demonstrated successful interactions with cross-functional project teams
• Solutions-oriented and skills/knowledge to manage complex problems and projects
• Use of IT validation eTools (i.e., JIRA, qTest, electronic record approval systems)
• Ability to work with minimal guidance and manage project deliverables and timelines

Company Description

E-CQR is a Texas based consulting company and offers a broad range of business solutions and technology services to help clients in achieving their business goals. Our top notch consultants are providing services to industry's top Pharmaceutical, Biotechnology, Medical device, Clinical research, Diagnostics, Chemical, Bio Medical, Drug development, Bioinformatics and Therapeutics companies.
Our strong company culture is built on the key values of trust, professionalism, commitment, excellence, and respect. These values are an integral part of our culture and form the foundation of long-term client relationships and lasting partnerships.

Interested candidates please send resumes to shrishty@ecqrinc.com

Company Description

E-CQR is a Texas based consulting company and offers a broad range of business solutions and technology services to help clients in achieving their business goals. Our top notch consultants are providing services to industry's top Pharmaceutical, Biotechnology, Medical device, Clinical research, Diagnostics, Chemical, Bio Medical, Drug development, Bioinformatics and Therapeutics companies.\r\nOur strong company culture is built on the key values of trust, professionalism, commitment, excellence, and respect. These values are an integral part of our culture and form the foundation of long-term client relationships and lasting partnerships.\r\n\r\nInterested candidates please send resumes to shrishty@ecqrinc.com