Manager, CSV

Job Description

Our team members are at the heart of everything we'do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Responsible for the planning, execution and documentation of CSV according to internal procedures and external requirements (e.g. GxP, GAMP 5, 21 CFR Part 11) Working with all technology teams by reviewing work carried out when necessary to identify compliance issues and improvements by providing advice or training. Evaluate our validation procedures to ensure they are efficient across the product base identifying where improvements can be made. Ensure our validation process and approaches are fit for ensuring both quality and speed to value to the business while maintaining compliance. Working with technology teams ensure the upkeep of documentation and evidence as required by standard operating procedures are being carried out. Representing the department processes and created/adopted solutions in external client audits. Risk assessing solutions being adopted for use internally and advising on best approach to ensure compliant system adoption. Approving Validation Plans, accountable for ensuring that a robust risk assessment and mitigation strategy has been implemented. . At least 6-7 years of computer system validation experience in a Life sciences and pharmaceutical environment. Good knowledge of cGxP regulations and software lifecycle approaches (e.g., GxP, GAMP 5, 21 CFR Part 11) Good communication skills What Cencora offers Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements. Full time Affiliated Companies Affiliated Companies: PharmaLex India Private Limited Equal Employment Opportunity Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned