39 days ago on jobs.celgene.com

Senior Specialist, Quality Assurance Compliance (Data Integrity)

Celgene Switzerland SA

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Senior Specialist, Quality Assurance Compliance (Data Integrity)

Senior Specialist, Quality Assurance Compliance (Data Integrity)

Req #:16001668
Job Category:Quality
Work Location:Boudry, Switzerland Route de Perreux 1 Boudry 2017
Organization:Celgene International SaRL
Shift:Day Job
Employee Status:Regular
Job Type: Standard
Job Level: Individual Contributor

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.

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, preferably with related computer systems administration experience.
Laboratory Technician, BS or MSc in Science, Computer Science or related field. Advanced training in laboratory or manufacturing IT systems (LIMS, MES) preferable.
Knowledge of Current Good Manufacturing Practices (cGMPs), Good Automated Manufacturing Practice (GAMP), Food and Drug Administration (FDA), and other regulatory requirements.  Strong knowledge in Health Authority regulations and guidances related to data integrity, data management, and Part 11 / Annex 11 compliance.
Proficient in the use of business, scientific and personal computer software and hardware, system security data collection hardware, operating systems and application software.
Very good understanding of solid oral dosage form manufacturing processes and QC testing methods are preferred.
Excellent interpersonal, collaborative and organizational skills.
Works independently on routine tasks including complex cases, makes decisions for minor issues.
Ability to focus attention to details.
Very good written & oral communication skills.
Demonstrated strong trouble shooting, investigational and QA problem solving skills. 
Very good knowledge of English, French would be an asset