Sr. Specialist, Quality Assurance Operations

Company : Bristol Myers Squibb

Job Type : Full Time

Boudry Ne

Number of Applicants

:

000+

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Job Description - Sr. Specialist, Quality Assurance Operations

Working with Us
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible. 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. Read more: careers.bms.com/working-with-us . Fixed term Contract : 1 year QA Operations team is committed to actively support Celgene/BMS Boudry manufacturing site and other departments to ensure cGMP compliant production, testing and release of product on the Boudry manufacturing site. This position is responsible for quality assurance (QA) involved primarily with the support of the different quality system tools in place to ensure cGMP compliance throughout the Boudry manufacturing site. You will be responsible for the assigned processes and activities within QA Operations. The activities include responsibility for execution of the main following processes: deviation and CAPA, change control handling, validation/ qualification activities and complaints considering cGMP, Computerized System and Data integrity guidelines. Additional tasks are risk assessments, as well as the support of health authorities' inspections and corporate audits. The Specialist, QA Operations can be assigned special tasks in cross-functional projects to support Boudry manufacturing site activities. This position will be working closely with the QA Operations management to identify and handle process quality and cGMP compliance related issues, as well as to contribute to process improvement in his/her scope of activity. This position will also support quality on the floor for manufacturing, packaging, warehousing, utilities, and QC activities in collaboration with the other members of the team of quality operation. The team works closely with the QA operation release team to achieve the site objective and release the products on time. As part of the quality on the floor organization, a capability to solve issues on call is required. The Specialist QA is also a key member of the site governance trough the tier meetings processes. You will be responsible to address the quality topics, take appropriate decisions at the right level, and bring any escalation to management, if necessary, in a clear and factual manner. This position is key to facilitate problems resolution at the right level. The Specialist, QA Operations can work autonomously, carry escalation, and follow all the topics from start to end in a proactive manner and behavior. Duties/Responsibilities
Participate to batch record review and prepare batch release documentation on support of the Quality release team.
Supports the deviation process. Ensure that the initial quality assessment is completed in a timely manner according to requirements, support investigators, assess the criticality, review, and approve the deviations and related CAPA.
Support the CAPA process by approving all the CAPA plan, and the completed action. Ensure review and approval of effectiveness check.
Support the change control process by performing QA impact assessment and action plan evaluation including Computerized systems and data integrity aspects.
Review and approve as QA representative qualification and validation activities documents from operational, data integrity and Computerized system perspectives (protocols, reports...) to ensure conformance to cGMPs, applicable industry standards and BMS requirements.
Contributes to risk assessments, e.g., related to quality issues or projects.
Represents QA within department and cross-functional project teams according to assignments.
Acts as backup for colleagues within QA Operations team.
Contributes to SOP/WP revision. Can take the ownership of processes and document revision.
Supports health authorities and internal inspections in different roles (SME, coordinator, etc...)
Participate to complaint process by completing minor complaint, working cross-functionally with relevant stakeholder (QC, Manufacturing, Stability group...
Qualifications
At least 5 years of experience in a pharmaceutical company or other related industry.
BS or MSc in Science or related field.
Good understanding of cGMPs and FDA regulatory requirements.
Good understanding of solid oral dosage form manufacturing processes is preferred.
Good Knowledge of most common office software (Microsoft Office).
Proven interpersonal, collaborative, and organizational skills. Ability to handle several tasks simultaneously.
Works independently on routine tasks, makes proposals, and facilitate decision when escalation is needed on straight forward cases or situations.
Ability to focus attention to details and analytical thinking.
Good written & oral communication skills.
Investigational and problem-solving skills.
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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