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Jubilant Pharma Holdings Inc.: Csv Compliance Specialist / Corporate Quality Systems

Jubilant Pharma Holdings Inc.

This is a Full-time position in Spokane, WA posted September 20, 2021.

Jubilant Pharmais seeking anCSV Compliance Specialist / Corporate Quality Systems(Remote ability)With a North American headquarters in Yardley, PA, Jubilant Pharma provides solutions to global pharmaceutical customers, offering a wide range of products & services.

We are a Company engaged in development, manufacture and supply of APIs, Solid Dosage Formulations, Radiopharmaceuticals, and Allergy Therapy Products.

Our services comprise Contract Manufacturing of Sterile Injectables, Ointments, Creams and Liquids.Position SummaryThe CSV Compliance Specialist / Quality System Coordinator is responsible for Quality oversite of corporate Computer System projects and data integrity requirements.Essential Functions(Essential functions, as defined under the Americans with Disabilities Act, may include the following tasks, knowledge, skills and other characteristics.

This list of tasks is illustrative ONLY and is not a comprehensive listing of all functions and tasks performed by positions in this class.

It does not imply that all positions within the class perform all of the duties listed, nor does it necessarily list all possible duties that may be assigned.)Assist in business requirement gathering, requirement analysis, business system design, installation, configuration, user testing and validation support of electronic Laboratory, Document, and Quality Management Systems (QMS/LIMS/eDMS).Lead and drive value-added LIMS, eDMS, SAP, and QMS expansion into applicable areas and departments.Troubleshoot problems with existing system configurations, master data, interfaces, and reports.Build business driven workflows, manager master data, and support computer system user communities.Support vendor qualification activities for software vendors and IT support consultants.Provides training support for new Jubilant Pharma computerized system users.Jubilant SME for computer systems and data integrity principles.

Assists IT in troubleshooting system and user-related issues during and after implementation.Assist in the identification and planning of new computer system solutions and enhancements to meet evolving business needs.Ensure a data governance program is established, adhered to, and reviewed for effectiveness across Jubilant Pharma.Lead Data Intergrity gap assessment efforts for new and existing regulatios as well as adherence to Jubilant Pharma policies.

Propose plan and corrective/preventive action for gaps.Lead efforts to develope Data Integrity Plan, including scheduling and prioritization of required activities, responsibilities, and timelines.Follow applicable standards and GxPs.Follows all company environmental, health and safety policies, procedures and guidelines and conducts work in a safe manner.Assistance with administration of the Jubilant Pharma Corporate Document Management Systems as needed.Performing computer systems / data integrity audits.Requires up to 25% travel to support computer system projects, and audits as required.Other duties as assigned.Experience and QualificationsTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

The requirements listed below are representative of the experience and education required:EducationBachelor’s degree in area of Life Science, Information Technology or related field.ExperienceMinimum of three years prior experience in a FDA-regulated industry.Knowledge and understanding of the computer systems development process and date integrity principles.Knowledge of GMPs/GxPs, ICH, FDA, and global regulations.Possesses the necessary technical and scientific knowledge.Minimum of three years requirements gathering, workflow design, configuration and documentation experience.Additional Preferred ExperienceProficiency in all standard business desktop applications (i.E.

Outlook, Microsoft, Excel).Working knowledge of Global Business processes.Strong interpersonal and communication skills.Effective oral and written communication skills.Experience with QMS, LMS, LIMs, and/or Document Management Systems desired.

~ Compensation based on experience ~~ Remote or in office ability~~ Relocation assistance eligible ~~ Jubilant Cadista offers an excellent benefit package which includes but is not limited to Health, Vision, Dental, 401K ~ It is the policy of Jubilant Cadista Pharmaceuticals, Inc.

(herein “Cadista”) to provide equal employment opportunity to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sexual orientation, gender identity and/or expression, marital status, status as a disabled veteran and/or veteran of the Vietnam Era or any other characteristic protected by federal, state or local law.

In addition, Cadista will provide reasonable accommodations for otherwise qualified disabled individuals.

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