Dirección
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To achieve the ambition, we have set for ourselves, we are looking for colleagues who are ready to live our ethos every day. Come be a part of this journey!
BAT MEXICO IS LOOKING FOR A (CSV) COMPUTER SYSTEM VALIDATION SCIENTIST
SENIORITY LEVEL: Junior Manager
FUNCTION: Digital Business Solutions
LOCATION: Monterrey, Mexico
ROLE POSITIONING AND OBJECTIVES
We are searching for a CSV Executive who will bring innovation, energy, efficiency, attention to detail and a positive attitude to our team. This position is an integral role within the U.S. Computer System Validation Team on the Scientific and Regulatory Affairs for the tobacco industry. It is responsible for the delivery of the Computer System Validation execution and management across the whole U.S. Market, will need to manage validation execution for new and existent systems for FDA Reporting.
Reports to: CSV manager
Geographic Scope: US
WHAT YOU WILL BE ACCOUNTABLE FOR
- Accountable for CSV of various systems across Operations, Manufacturing, DBS and other areas in U.S. Market
- Create / Execute high-quality deliverables (e.g., SDLC documentation, IQ, OQ, PQ, Summaries) utilizing approved formats
- Execute enterprise-level policies and procedures for implementation of validation elements
- Participate with Validation Compliance Management to develop framework and processes for validation-relevant elements in accordance with applicable corporate strategies and regulatory requirements
- Manage change control for validated systems
- Effectively communicate validation strategy and framework to diverse clientele
- Meet agreed-upon timelines, including delay mitigation
- Identify process improvements and efficiencies
- Provide metrics for business reporting
- Communicate statuses, concerns, issues, etc. to stakeholders at all levels
- Maintain knowledge of current best practices and providing strategic recommendations and services to Company
- Collaborate with stakeholders to create and maintain project timelines for assigned projects and tasks
- Provide consensus and direction on change controls with input, as appropriate
- Create and provide routine written status reports on assigned projects at requested frequencies
EXPERIENCE, SKILLS, KNOWLEDGE
• Experience managing qualification, or validation in a regulated industry
• Proficient in verbal and written communication in English
• Proficient with Computer Systems and general terminology
Technical / Functional / Leadership Skills Required
- Results-oriented with the ability to prioritize and multi-task to meet validation timing and methodology requirements
- Strict adherence to process and protocol
- Acute attention to detail
- Capability for intense technical reading/writing
- Solid interpersonal skills with ability to interact and collaborate with all levels of the organization
- Team-oriented demonstrating strong collaboration skills with business partners
- Demonstrated project management skills
- Demonstrated ability to dissect and streamline processes
- Ability to identify potential regulatory risks to the Business and ensure proper controls are in place
- Ability to draw relationship between system functionality and regulatory requirements
- Ability to manage conflicting priorities
- Demonstrated technical leadership skills
- Ability to work independently and drive execution with a sense of urgency
- Ability to make decisions and recommendations with minimal oversight
- Ability to discern when to escalate issues
Education / Qualifications / Certifications Required
Bachelors of Science degree with relevant experience (3+ years);
BENEFICIAL
- Understanding of current regulations and validation strategies
- Willingness and ability to achieve and maintain validation and regulatory knowledge through job experience and with ongoing courses and seminars.
- Experience working with manufacturing or laboratories
WE ARE BATAt BAT we are committed to our Purpose of creating A Better Tomorrow. This is what drives our people and our passion for innovation. See what is possible for you at BAT.Global Top Employer with 53,000 BAT people across more than 180 markets
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Seal Award winner – one of 50 most sustainable companiesBELONGING, ACHIEVING, TOGETHERCollaboration, diversity and teamwork underpin everything we do here at BAT. We know that collaborating with colleagues from different backgrounds is what makes us stronger and best prepared to meet our business goals. Come bring your difference!Apply
