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Form of workAbout the roleNovartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. The Batch Record Coordinator is responsible for life cycle management of issued labels and documentation as well as the timely and effective GMP review of production records.MES/SAP/LIMS Super User to include floor support and training.• SPOC for Batch Record Process includes creating reports; productionterminating and approving records; issue resolution.• Reviews all batch documentation for accuracy and completeness according tocGMP's to ensure timely release.• Ensures deviations are initiated for any Batch Record review related eventsFind/communicate deviations to QA /help with investigation• Adheres to internal/external guidelines, specifications and regulatoryrequirements while reviewing batch documentation.• Ensures all GMP's, Work Procedures and SOP's are followed.Addresses deficiencies and ensures completion of all follow-up actions,specifically those that target process fixes to maintain consistent resolutions toall batch review issues according to GMP standards and Novartis objectives.Provide periodic updates at Manufacturing Team meetings to review currentBatch Record errors to improve performance.• Maintains strong collaborative relations with the Quality GroupCommitment to Diversity & Inclusion: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 other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.Role RequirementsBS degree or equivalent pharmaceutical experience.Strong background in Good Documentation Practices1 -3 years experience in a regulated cGMPEnvironment.Strong aseptic manufacturing knowledge preferred.Must be able to speak EnglishThe pay range for this position at commencement of employment is expected to be between $31.74 and $47.60/hourly; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.
If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook: https://www.novartis.com/careers/benefits-rewardsAccessibility and Reasonable Accommodations:The Novartis Group of Companies are 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 tas.nacomms@novartis.com call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/networkSalary: .
Date posted: 11/16/2023
