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Sr. Specialist QA documentation-Training and Compliance
View: 172
Update day: 25-02-2024
Location: Boudry Neuchâtel NE
Category: Quality Assurance / Quality Control
Industry: Pharmaceutical Manufacturing
Position: Entry level
Job type: Full-time
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Job content
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.This position is within the Global Internal Manufacturing Quality Operations organization, reporting to the Sr Manager, QS & Compliance.
As part of the QA Documentation & Training team, the Sr. Specialist is responsible to support the Quality Document Management System for BMS Internal Manufacturing Boudry as well as some associated organizations.
Moreover, you will support the GMP/GDP Training system, including the maintenance of the LMS for the above-listed locations.
Additionally, the Sr. Specialist will actively support Celgene/BMS Boudry manufacturing site and other departments to ensure cGMP compliant processes.
The activities include the participation in following processes self-inspections, health authority inspections, annual product review reporting, and product quality complaints.
Skills/Knowledge Required
- At least 2 years of experience in a pharmaceutical company or other related industry, ideally in Quality Assurance
- BS in Science or related field.
- Experience in handling controlled Quality Documentation & Training in a regulated environment
- Fluent in French, working knowledge in English (B2)
- Very good understanding of cGMPs and regulatory requirements
- Excellent interpersonal and collaborative skills
- Good organization skills and priority management
- Works independently on routine tasks, makes decisions for minor issues
- Comfortable providing training/guidance to systems users as needed
- Ability to focus attention to details
- Good communication and ability to work in a multicultural and evolving environment
- Knowledge of most common office software (Microsoft Office)
Documentation management
- Ensure Quality Documentation complies with established BMS Electronic Documentation Management System procedures& policies
- Act as QA Documentation reviewer and approver within the Document Lifecycle Management workflow
- Provide timely and efficient support to the EDMS & LMS users in handling document workflows and document change requests
- Monitor progress of documents in workflows, ensure timely follow-up and completion
- Monitor the Periodic Review Process of documents
- Print /issue document controlled copies and logbooks and ensure their controlled distribution in collaboration with requesting department
- Work in close collaboration with hiring managers to collect and complete onboarding activities for new employees/contractors
- Responsible for the creation and assignment of GMP/GDP training in BMS electronic Learning Management system (Compliance Wire)
- Create, update and assign Personnel Training profiles and curriculum in accordance with Training management requests
- Coordinate curriculum review, user group or user profile review, as well as assignment of job description in LMS.
- Ensure Documentation & Records are archived, retained and destructed in compliance with BMS retention requirements (storage, retrieval for consultation, destruction)
- Provide support and guidance to document owners /departments for documents and records archiving process
- Complete physical & electronic archiving process using File Trail, as well as archives periodic reconciliation
- Supports the product quality complaints process by handling complaints and executing investigations as assigned
- Write the annual product reports for products made at the Boudry manufacturing site
- Contribute to the preparation and execution of authorities inspections and corporate audits in different roles (i.e. back office, subject matter expert, note taker or runner) for Boudry
- Supports internal audits by executing self-inspections and ensuring on-time completion of action plans.
- Coordinate data collection and support response to regulatory authorities’ requests e.g. in the scope of submission or periodic GMP review
- Contributes to regular reporting of quality processes metrics for different review meetings
- Assists with writing SOPs and makes recommendations for SOP revisions for the Quality Operations and supported departments of Boudry manufacturing site
- Supports the deployment and execution of GMP training intended for all Boudry manufacturing sites departments involving GMP activities
- Act as Administrator and Super User of the electronic Documentation Management System & LMS Compliance Wire.
- Assist with the development/writing of procedures in relation with document management, archiving system and LMS system.
- Acts as deputy for colleagues within QS &Compliance team
- Provide support in the preparation of the required documentation during internal audits and/or external inspections.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
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Deadline: 10-04-2024
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