Job Description

Summary of the position:This position is to assure that the creation, implementation, and maintenance of computer systems, validation standards, and processes result in GxP-compliant, high quality solutions which are fit for their intended use.Provide support to the Alcon Global e-Compliance team through oversight and guidance to assure that Alcon GxP-relevant IT systems and Infrastructure are in compliance with applicable regulations and the Alcon Quality Management System.Major Accountabilities and ResponsibilitiesTake direction from the Global e-Compliance team to provide support of all ongoing activities related to the development and implementation of GxP/CSV and eCompliance related aspects in the IT and QA policies, quality manuals, standards and procedures. Work with specific projects to provide compliant implementation of computerized systems to meet GxP requirements. Provide guidance in the development and delivery of compliant IT systems. Partners with IT to conduct a compliant computer systems validation process for all applicable GxP applications. Review/audit and/or approve the key validation documents for computerized systems within the Alcon division and business unit scope (e.g. Systems Inventory, Quality Plan/Validation Protocol, GxP Risk-Assessment, Validation Report, and GxP relevant changes and deviations). Identifies current and anticipated requirements for compliant computerized operations and suggests methods for identification, implementation, maintenance of procedures and actions to assure compliance according to (federal and international regulations). Reports on the status of validation activities to fulfill regulatory requirements. This role requires adherence to specific cGXP requirements and execution according to the valid SOPs. Reviews GMP documents related to Computer system validation, changes, deviations, provides oversight, and approval of all activities related to operational support. Play an active role in the ongoing eCompliance function, including participating in teams to assure consistent, standardized and compliant implementations. Support of e-Compliance related internal training programs and events Identifies current and anticipated requirements for compliant computerized operations and suggests methods for identification, implementation, maintenance of procedures and actions to assure compliance according to (federal and international regulations) This role requires adherence to specific cGXP requirements and execution according to the valid SOPs.Education:Bachelors degree in IT, Computer Science, Business or equivalent fieldLanguages:EnglishExperience:Minimum of 5 years CSV / IT work experience with 3+ in a regulated medical device/Pharmaceutical industryKnowledge of the current ISO 13485, CSV (GAMP 5) and Electronic Records/Signature requirements for automated systems and software applications as well as of the general regulatory guidelines (FDA, EU, PIC/S, ICH etc.).Support project teams and Global e-Compliance Managers to carry out all team specific tasks in time.Direct, clear and prompt communication to team members, peers, superiors and prospective customersUnderstanding of GxP environments and health authority requirements for system validationExperience with formal project methodology (e.g Waterfall, Agile, CMM, Six Sigma, RUP, etc.)Self-starter with results oriented track record including demonstrated experience in the implementation of IT solutionsGood interpersonal skills, with an ability to effectively manage customer relationships with internal and external partnersEmployment scams: Alcon is aware of employment scams which make false use of our company name or leaders names to defraud job seekers. Alcon does not offer any positions without interview and never asks candidates for money. All our current job openings are displayed here on the Careers section of our website, where you can search for open positions and apply directly.
If you have encountered a job posting or been approached with a job offer that you suspect may be fraudulent, we strongly recommend you do not respond, send money or personal information, and check our website for current job openings.ATTENTION: Current Alcon Employee/Contingent WorkerIf you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.Alcon is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital status, disability, or any other reason.

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