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 Responsibilities

Take 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 SOP’s. 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 SOP’s.

Education:

• Bachelor’s degree in IT, Computer Science, Business or equivalent field

Languages:

• English

Experience:

• Minimum of 5 years CSV / IT work experience with 3+ in a regulated medical device/Pharmaceutical industry

• Knowledge 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 customers

• Understanding of GxP environments and health authority requirements for system validation

• Experience 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 solutions

• Good interpersonal skills, with an ability to effectively manage customer relationships with internal and external partners

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