New job CSV Senior Consultant / Manager -- Raritan, NJ -- Full-Time Opportunity

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Group: Technology Recruiters Subject: CSV Senior Consultant / Manager -- Raritan, NJ -- Full-Time Opportunity Syed Yaseen Ahmed posted a job: CSV Senior Consultant / Manager -- Raritan, NJ -- Full-Time Opportunity "Position: CSV Senior Consultant / Manager Location: Raritan, NJ Job Type: Full-Time Opportunity We need CSV profiles for Raritan, NJ. There are three open positions for this type role. The JD is as below: The CSV Senior Consultant will act as a confidante to the senior director of quality & compliance across Client Pharma, consumer and medical devices groups. SUMMARY: Senior Consultant/Associate Director Quality Assurance - Computer Systems Validation to assist with computer systems validation. The successful candidate will lead a team of consultants to write, review, approve and implement related policies and SOPs as required. RESPONSIBILITIES: • Drive Compliance across multiple groups with regulatory and company standards for Computer System Validation • Ensuring appropriate standards and procedures are in place to support CSV and commensurate compliance requirements. These includes oversight for the use of existing System Development Life Cycle and for ensuring validated, compliant and business effective computerized systems are fully defined, deployed and controlled • Providing leadership, guidance and support to the IT and QA organizations and project teams to ensure harmonized and consistent use of CSV standards, templates and procedures for computer system validation for Enterprise Systems with focus on GMP / regulated systems and technologies • Development and implementation new system development life cycle requirements • The position will report to the Senior Director QA Global Standards and will interact with IT, Regulatory Affairs, as well as other departments and manufacturing facilities as necessary. REQUIREMENTS: • BS in life sciences or IT with 10-15 years of experience in the pharmaceutical or biotechnology industry • Experience with Computer Systems Validation review and approval. • At least 5-7 years managing progressively more complex computer systems validation projects. • Technical competent in GAMP guidelines and knowledgeable in evaluating systems lifecycle principles. • Ability to apply advanced validation engineering principles to the design and implementation of projects. • Sound knowledge of IT Infrastructure. • SAP applications and modules preferably in supply chain environments, and Information Database Systems and relational database engines is a MUST. • Strong knowledge of FDA guidelines and regulations regarding GMPs and 21CFR Part11Demonstrated leadership and ability to form, lead and manage teams with consultants from the Big 4 ( MUST HAVE) • Demonstrated team player with experience contributing to multi-disciplinary project teams and ability to work with minimal supervision • Outstanding written and verbal skills as well as problem solving skills Strong initiative and ability to assume significant project management skills • Ability to work in a fast-paced, dynamic, environment Thanks & Regards, Axius Technologies Syed Yaseen Ahmed - Sr. Technical Recruiter Voice: 703-738-6662 EXT 137 Email ID: yaseen@axiustek.com"

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