Lead Data Integrity Site Job The Estée Lauder Companies Blaineby admin on December 20, 2020
The Estée Lauder Companies Job Vacancies 2021Description :
- Leads Data Integrity Rollout strategy at the respective site
- Directs the efficient and effective execution of Data Integrity requirements across the site/campus
- Liaisons with relevant cross-functional team ( DI Site program managers globally, mfg sites, R&D, IT, other) to coordination DI activities to leverage scale and maximize efficiencies accordingly.
- Collaborates with other DI site program managers to share best practices and harmonized processes across the global mfg sites
- Initiates and manages any DI work processes required for assigned program ( including Change Management) to ensure site is compliant
- Resolves timeline issues related to executional deliverables and develops tactical plans when necessary to bring back on track.
- Ensures Day to Day discipline to project plan and call out any risk of timeline gaps
- Ensures implementation of continuous improvement and process improvements programs
- Responsible to establish current state and work to drive remediation efforts and sustainable solutions
- Responsible for managing the DI compliance on all GxP Computerized Systems Instruments and Equipment
- Individual is responsible for technical management of all GxP computerized systems used at the respective site. This responsibility would include working with individual scientific, manufacturing system vendors, and drafting and maintaining current compliant system documentation, compliant training procedures and documentation, etc. This responsibility also requires developing and documenting the processes for the Equipment/Instrument management role.
- Provide leadership to ensure that all initiatives are appropriately and effectively managed, documented and monitored for optimum efficiency and effective roll out.
- Coordinate all future system rollouts, scientific applications and new system upgrades
- Coordinate with Plant Operations team and site QA to conduct periodic, hands-on audits and an annual physical inventory verification of computerized systems throughout the site to ensure that systems are current and continue to function appropriately for current usage in Est e Lauder
- Coordinate, execute and document all System User Verification for data integrity and compliance requirements.
- Ensure all GXP applicable systems have CSV (Computer System Validation) documentation and procedures in place
- Ensure all computerized systems have appropriate back up procedures
- Corporate IT has procedure are in-place for IT managed systems
- Site-wide stand-alone computerized system backup procedures are in-place and periodically tested for non-networked systems.
- Works closely with the business stakeholders on business requirements, manages technical feasibility analysis, and financial analysis of proposed process and technical solutions.
- Leads and manages the effective execution and implementation of computerized projects across the entire site including QA labs
- Ensure production releases meet business expectations and adhere to standards.
- Strong knowledge of Program Management, Project Management, Supply Chain processes
- Effective communication with business stakeholders and project stakeholders.
- Ensures adherence to System Development and Life cycle (SDLC), FDA Validation, CFR 21 Part 11 and Change Control management processes requiring a detail knowledge of the Quality Systems inclusive of Change Control, CAPAs and Deviation procedures.
- Minimum of 5 years of relevant experience
- Experience in staff management with proven ability to manage and collaborate in a multi-location, multi-vendor environment with an emphasis on process documentation and training.
- Must be an excellent team player with strong analytical skills, negotiating and communication skills
- Strong program management skills including follow-up and organizational skills required
- Ability to use computer systems necessary to meet objectives including Microsoft Office, MS project, SAP
- Experienced in Supply Chain processes and systems in a Fortune 500 CPG company.
- Experienced in managing various laboratory equipment and systems in a highly dynamic corporate landscape
- Experienced in writing SOPS and Work Instructions and other Quality System Documents.
- Knowledge of GXP (Good Clinical/Manufacturing/Documentation practices)
- Knowledge of FDA Validation and CFR 21 Part 11
- Knowledge of Various software applications and SAP ERP a plus
- Knowledge in Data Infrastructure/Security background is plus as well as any data Integrity & integration experience.
- Modern HTML 5 and CSS skills e.g. responsive design
- Competent in OO programming languages, specifically Java
- Experience with Version Control technologies, ideally Git
- SQL based languages (MySQL, MSSQL)
- An understanding of Restful API concepts
- Understanding of Unix based systems, Terminal commands
- Understands concepts of containers, e.g. Docker
- Key concepts behind NoSQL databases.
- IOS development skills
- Cloud principles
- Bachelor's Degree
- 10% Travel
Job: Information Technology
Primary Location: US-MN-Blaine
Job Type: Standard
Shift: 1st (Day) Shift
Job Number: 2010155
We are an equal opportunity employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply. It is Company's policy not to discriminate against any employee or applicant for employment on the basis of race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. The Company will endeavor to provide a reasonable accommodation consistent with the law to otherwise qualified employees and prospective employees with a disability and to employees and prospective employees with needs related to their religious observance or practices. Should you wish to apply for this position or any other position with the Company and you believe you require assistance to complete an application or participate in an interview, please contact [email protected]
For more detail information, please refer official source from The Estée Lauder Companies on following link below :
Please note that we do not accept any CV submissions. If You want to apply for a job that you have discovered on karomall.com, simply click on the provided job application link and follow the instructions afterwards. You'll be taken to a more detailed page.