- Responsible for assisting Technology & Data Quality Assurance in overseeing the Computerized Systems Validation Program
- Responsible for representing Technology & Data Quality Assurance on Information Systems Compliance program related continuous process improvement initiatives.
- Provides guidance to drive consistent GxP and Electronic Records / Electronic Signatures regulations compliance and validation approaches across projects to ensure compliance with regulations, and Astellas policies and procedures.
- Responsible for reviewing and approving Computer System Validation documents to ensure compliance with written policies and procedures.
- Schedules and performs assigned computerized systems audits related to the purchase or use of software.
- Supports new technology initiatives as the company continually invests in new technology solutions, related processes, and computerized systems.
- Integral QA representative in numerous IT project teams. Participates in working teams to provide direction regarding quality, validation, and compliance.
- Performs and coordinates the review and approval of validation deliverables including, but not limited to, computer system requirements, validation plans, test protocols, traceability matrices, executed testing documentation, and validation reports.
- Work with IT staff to resolve issues identified during document reviews.
- Assures compliance with corporate policies, SOPs, and regulatory agency standards (US, EU, and Japan, as needed). Identifies compliance issues and works with CSV QA staff to identify and implement corrective action as required.
- Communicates compliance issues to TDQA Management.
- Conducts and coordinates compliance and quality training to peers, other departments, and external customers as assigned.
- Schedules and performs assigned software vendor audits of newly identified or current, regulated and business critical software vendors. Plan, conduct, and report results of assigned audits.
- Assist with good manufacturing practice (GMP), good clinical practice (GCP), or good laboratory practice (GLP) audits of manufacturing sites, laboratories, investigational research centers, software providers, and related functions, as needed. Assess the adequacy and compliance of computer system development, testing, validation, and management procedures and documentation at these facilities/sites.
- Effectively and accurately document audit findings in audit reports and obtain responses in a timely fashion.
- Assist in the evaluation of audit responses for compliance with applicable guidelines, regulations, and Astellas policies. Obtain remediation when responses are unacceptable.
- Identify the levels of knowledge, skills, abilities, experience and education required for the position.
- Minimum B.A. / B.S. with at least 3-5 years in Quality Assurance position within pharmaceutical environment or healthcare field. Experience in IT Compliance roles will be considered.
- Must have Computer System Validation experience. Computer System Validation Quality Assurance / Software Quality Assurance experience desirable.
- Must understand global regulatory requirements for electronic records and electronic signatures including but not limited to: US CFR 21 Part 11, EU Annex 11, EU Directive 1999/93/EC, and Japan PFSB Notification No Must understand associated regulatory guidance documents.
- Must understand computer systems validation process, and process controls in the areas of GAMP 4 / GAMP 5, ISO 9000, ITIL, IEEE, and ASQ standards.
- GxP computerized auditing experience required; Pharma, GMP, GCP, and GLP auditing experience desirable. Ability to represent the company to external stakeholders during vendor audits required.
- Effective written and oral communication and interpersonal skills, facilitation, and influencing skills with an ability to develop and maintain effective relationships across Astellas groups and external stakeholders.
- Must be capable of managing self and project teams across multiple assigned projects.
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Computer System Validation Consultant - New York, United States - SPECTRAFORCE
Description
Job Title: Technology and Data Quality Assurance (TDQA) Consultant (CVS)
Location: North brook, IL (Remote)
Duration: 10 months
Primary Responsibilities:
Essential Job Responsibilities:
Required Qualifications:
About Us: Established in 2004, SPECTRAFORCE is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of "human connection," defined by our branding attitude of NEWJOBPHORIA, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at:
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at if you require reasonable accommodation.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.
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