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Senior Specialist, Quality Assurance Compliance (Data Integrity)
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Job Description:

Description Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture. The role : QA Compliance is committed to actively support the Celgene manufacturing sites and contract manufacturers in the International region to ensure cGMP compliant processes. This position is responsible for Quality Assurance (QA) activities established primarily to ensure Data Integrity of QC, manufacturing and other relevant processes and/or systems according to cGMP. The scope of the position covers the manufacturing sites in Boudry, Couvet, and Zofingen (API), as well as contract manufacturers and laboratories in the EMEA region. The position holder will be responsible to review and define procedures for data review (both paper and electronic), in collaboration with other departments and the Celgene Global Quality group. The activities include responsibility for execution of the main following processes: Assessment and development of internal processes and practices for data review (laboratory or manufacturing operations) to ensure alignment with current and evolving Health Authority (HA) expectations and industry best practices with a focus on processes and practices for data integrity, including data review and approval. The Senior QA Compliance Specialist can be assigned special tasks in cross-functional projects to support Boudry manufacturing site activities, health authority inspections or corporate and internal audits. As a member of the Quality Operations department, this position will be working closely with the QA Compliance management and other departments to identify and handle data integrity and cGMP compliance related issues, as well as to contribute to process improvements in his/her scope of activity. Duties and responsibilities: a. Lead the implementation of Corporate procedures and work practices governing associated processes to ensure data integrity at the Boudry manufacturing site and other sites in the International region. b. Be the local Subject Matter Expert (SME) to establish data integrity requirements related to laboratory and manufacturing data. c. Review current programs for raw data review and approval, including scope and frequency of review/approval and responsibility (e.g. peer review, supervisor review, QA review, etc.) and determine best practices based on HA requirements, industry guidance and best practices. d. Use and further develop Data Integrity checklists to assess all (laboratory or manufacturing) processes and systems at the Boudry manufacturing site and other sites in the International region for compliance with the requirements. Develop action plans with impacted departments and managers for identified gaps and provide guidance, oversight and support for resolution. e. Perform assessment of laboratory and manufacturing processes and practices for compliance with global data review requirements, and identify actions to update procedures, processes, etc.. Considerations include, but are not limited to, how to: • Review data and documents • Review audit trails; • Search for un-reviewed data and establish process for follow up; f. Assists with writing SOPs and makes recommendations for SOP revisions for the Quality Operations and supported departments of Boudry / Couvet / Zofingen manufacturing sites, as process owner for Data Integrity. g. Provides support and guidance to other departments and functions in the International region for Data Integrity topics. h. Provides Quality Assurance oversight of the Boudry QC laboratory operations including but not limited to • Stability program QA oversight and data review • QA approval and/or SME input on critical change controls • Support investigation of OOS and / or major or critical laboratory deviations • QA review and communication to QP of any deviations that may impact product disposition i. Supports authorities inspections by participating in the preparation and the progress of the authorities inspections in different roles (i.e. back office, subject matter expert, note taker or runner). Can also support case by case corporate and internal audits. j. Represents QA within department and cross-functional project teams according to assignments. k. Manages complex tasks, involvement in cross-functional topics including other Celgene entities and Corporation. Qualifications Skills and knowledge required: • At least 5 years of experience in a pharmaceutical manufacturing environment with cGMP requirements or other related industry, with strong knowledge of QC laboratory and/or manufacturing systems, prefer

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