Senior Specialist, QA Operations
Apply locations Boudry - CH
Time type: Full time
Posted on: Posted 2 Days Ago
Job requisition id: R1588881
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.
QA Operations Team The 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.
Responsibilities You will be 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. This includes:
Execution of processes including deviation and CAPA, change control handling, QA oversight of validation and qualification activities.
Risk assessments and support of health authorities inspections and corporate audits.
Working closely with QA Operations management to identify and handle quality process and cGMP compliance related issues.
Supporting quality on the floor for manufacturing, packaging, QC, and warehousing activities.
Participating in site governance and addressing quality topics during tier meetings.
Working autonomously, carrying escalation, and following all topics from start to end in a proactive manner.
Duties/Responsibilities Support the deviation process, ensuring timely quality assessments and approvals.
Support the CAPA process by performing QA impact assessments and approving plans.
Support the change control process, reviewing and approving Change Control.
Review and approve Qualification and Validation activities documents.
Contribute to risk assessments related to quality issues or projects.
Represent QA within department and cross-functional project teams.
Act as backup for colleagues within QA Operations team.
Contribute to document revisions and take ownership of processes.
Support health authorities and internal inspections.
Participate in Quality KPI establishment and monitoring.
Manage the product quality complaints process.
Provide regulatory compliance support across the end-to-end product lifecycle.
Qualifications BS or MSc in Science or related field.
At least 5 years of experience in a pharmaceutical company or related industry.
Good understanding of cGMPs and FDA regulatory requirements.
Good understanding of solid oral dosage form manufacturing processes is preferred.
Proven interpersonal, collaborative and organizational skills.
Ability to handle several tasks simultaneously and work independently.
Attention to detail and analytical thinking.
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work.
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.
BMS cares about your well-being and recommends that all employees be fully vaccinated for Covid-19.
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