About the Company
Regenesis is seeking an experienced Computerized Systems Validation (CSV) Engineer to oversee and perform CVS activities ensuring that business processes required to operate are qualified and maintained in a validated state according to company directives and procedures. The successful candidate will have advanced knowledge and experience developing and leading CSV and life-cycle management activities to support GxP conforming systems, facilities, and manufacturing. The CSV Engineer understands industry-wide and regulatory expectations for CSV and works with members of IT, QA, and stakeholders to ensure that CSV packages are consistent with validation plans and standard operating procedures and utilizes industry experience to identify continuous improvement opportunities for CSV practices. This position will also support other areas of the Regulatory Affairs & Quality Assurance department such as auditing, supplier qualification, CAPA, and additional tasks determined by management.
About the Role
Conception, planning and performing of Computer Systems Validation (CSV) in the regulated environment. Advisory and support of application owners to build and maintain GxP conforming systems and ensure compliance with applicable regulations and industry standards. Implementation of qualification/validation requirements for new and existing computer systems. Support development and implementation of IT procedures that adhere to Data Integrity requirements as defined in applicable regulation for Raw-Data-Handling systems and solutions. Oversee and perform CSV activities and ensures the approach and execution aligns to applicable regulations and Regenesis’ directives and procedures. Develop/improve and implement CSV documentation such as VPs, Test Scripts, Risk Assessments, Reports, SOPs, Policies. Support the implementation and adoption of the corporate CSV program and remediation. Support data integrity implementation within CSV program. Participate in audits and continuous improvement efforts related to CSV program. Qualify software, infrastructure vendors. Perform internal and external audits. Support the CAPA process. Participate in FDA inspections and 3rd party audits. Other such duties as determined by management.
Responsibilities
Qualifications
Equal Opportunity Statement
As an Equal Opportunity Employer, all qualified candidates will receive consideration for employment without regard to race, color, religion, sex, national origin, genetic information or protected veteran status and will not be discriminated against on the basis of disability.
...thenewcadent.com. We are looking a motivated and detail-oriented intern to join our Client Services team! This internship will offer... ...and maintaining up-to-date records in our databases known as Salesforce, Platform, JIRA and more. Help prepare client presentations,...
...Blair Freeman, an Omaha based construction company is currently hiring for a Construction Project Manager who will be responsible for both commercial and residential construction. This will include all aspects of construction including estimating, budgeting, procurement...
...solutions in Epic Requirements: Fluency in Chinese (Cantonese and/or Mandarin) is required. Associates degree or higher in nursing or related field. Active, Current and Unencumbered RN license in CA Current BLS and First Aid required Preferred...
...Position Overview: The primary responsibility of the Producer Events is to plan, organize, and execute a variety of events. Managing strategic partnerships that drive brand awareness, customer acquisition, and revenue growth. All duties are to be performed in accordance...
...Work and a minimum of one year of experience working as a Social Worker in a health care setting AND/OR ~ Current State of California... ...Clinical Social Worker (LCSW)~ Must have current Basic Life Support (BLS) Certification. ~* Must meet all DMV requirements below...