e-Compliance Manager - FT. Worth or Remote
•Serves as an Alcon Division e-Compliance manager, 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 oversight and guidance to assure that Alcon GxP-relevant IT systems and Infrastructure are in compliance with applicable regulations and Novartis Quality Modules.
- Oversees and manages 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
- Support of inspection preparation activities related to e-compliance and data integrity
- Executes the Alcon Data Integrity Program as required according to related targets.
- Lead and/or support e-compliance or data integrity topic related work streams
- 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
Alcon is an Equal Opportunity Employer and participates in E-Verify. As part of the Novartis Group of Companies, Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information
alrpo EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Minimum requirements •Bachelor's degree in IT, Computer Science, Business or equivalent field
- Minimum of 7 years QA / IT work experience with 3+ in a regulated medical device/Pharmaceutical industry in an information technology related position
- Working knowledge of audit functionality.
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