Job Summary
This position will coordinate and lead the QA-CSV program associated with all CSV related projects at Amneal, creation and maintenance of CSV change controls and related documents to ensure consistency with established standards. This position will also be responsible for initiating the periodic review of GxP computerized systems to assure adherence to Amneal standards and procedures. Work independently with other departments to ensure adherence to QA-CSV procedures as new systems are being implemented or updated. Provide QA-CSV review and regulatory guidance on computer systems validation to Amneal functional areas and locations, as needed
Essential Functions
Provide guidance on validation activities for projects involving GXP relevant computer systems in conjunction with the Functional Validation Lead to incorporate appropriate elements of quality and compliance into the system life cycle. Computerized System Risk Assessments that are completed by the business.
Provide CSV support for all computerized systems that are implemented, upgraded, or retired at Amneal.
Approve Software Development Life Cycle (SDLC) deliverable and activities to ensure that procedures and methodologies are followed, and that appropriate and complete documentation is captured and reported to support SDLC activities for assigned IT systems, including associated change requests.
Consult on the authoring and conformance of SDLC deliverable and activities in regard to company SOPs, policies and current regulations.
Represent Quality Assurance on all assigned IT projects in support of SDLC activities.
Provide guidance and support to IT personnel in their SDLC efforts, to ensure compliance.
Schedule and approve periodic reviews for all GxP Computerized Systems.
Provide quality assurance oversight for system related issues.
Participate in project planning to assure thoroughness of validation planning.
Additional Responsibilities
Create and review standard operating procedures as they relate to computerized systems.
Initiate computer systems deviation in the QMS and/or provide investigations, as needed.
Other relevant duties as assigned.
Education
Bachelors Degree (BA/BS) inRelated field -Required
Work Experience
5 years or more inQuality and Systems Compliance and / or Validation -Required
5 years or moreFDA regulated environment with strong understanding of cGXP standards and Rick based validation. Developing or reviewing system Validation Plans, Requirements, Design Specifications, Test Protocols, Deviation management, Traceabilty matrix and Validation Summary reports. Change Control. -Required
Skills and Abilities
Must be capable of handling multiple tasks and prioritizing work in a fast paced dynamic work environment. -Advanced
Strong verbal and written communication skills. -Advanced
Specialized Knowledge
Knowledge of FDA guidances and industry standards (i.e., Quality Systems, GAMP, 21CFRPart11)
Specialized knowledge of a particular functionality e.g. laboratory instrumentation, or manufacturing processes, preferred
