As Validation Engineer (CSV) you will be part of our Quality Department for Philip Morris Polska S.A.
In your role, you will ensure manufacturing process and Local Computerized Systems are appropriately qualified and validated. In addition, you will be responsible to lead and execute validation activities identified and required.
In this position, you will also ensure the review of documentation and leading quality risk assessment as well as support change management activities.
• Lead and execute validation activities that are identified and required (process, cleaning, CSV)
• Support all aspects of Computer System Validation. Assure that all computerized systems are validated in accordance with xGMP principles, regulatory requirements, and company policies and standards.
• Become a subject matter expert (SME) in Computer System Validation (CSV), provide technical expertise and guidance to management and cross functions.
• Provide risk assessment for new computer systems and changes to existing computerized systems
• Execute and provide reviews of validation protocols and validation periodic monitoring
• Manage the validation of new computerized systems, as well as changes to existing systems, and work closely with cross functions to ensure that CSV requirements are met
• Write, execute, or review CSV documents in a timely manner: Validation Plans, Tests, Reports, (i.e. VP, SRRAF, FRA, IOQ, UAT, TM, VR, etc.) and Deviation Handling (Support the resolution of deviations and/or errors and provide quality guidance on GxP regulatory requirements
• Prepare all the documentation associated by ensuring the execution following the plan.
• Ensure that all validation activities are carried out and reported in a timely manner.
• Ensure that all deviations during validation activities are investigated and escalated when required. Propose action plans and ensure that correctives/preventives actions are followed and closed on time.
• Organize and lead the Continued Verification Assessment and the re-execution of validation protocols according to the plan and procedures.
• Provide reports and other documentation associated with validations, as appropriate for each validation exercise
• Lead and coordinate change management process in the factory and ensure validated state of the manufacturing processes, methods and systems is maintained. Ensure the reporting and the update of key metrics.
• University degree in Science/Engineering or equivalent
• Experience in qualification and validation of manufacturing processes and Computerized Systems
• Fluent oral and written communication skills in Polish and English
• Knowledge of ISO Management Systems
• Experience in auditing of organization internally or externally against ISO 9001 - will be anasset
• Strong communication, negotiation, ability to coach, technology & business process acumen, deal with ambiguity, managerial courage, result oriented, project management
• Good practical knowledge of MS Office (Excel, Word, etc.)
APPLY ON-LINE IN ENGLISH AT WWW.PMICAREERS.PL BY 17.06.2019
Please note that only on-line applications will be taken into consideration. Only selected candidates will be contacted