400px Bristol Myers Squibb logo 2020.svg 18 QA Validation Senior Specialist

QA Validation Senior Specialist

Bristol Myers Squibb

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 until 31/12/2025

The BMS site of Boudry is a Pharmaceutical Manufacturing Site for Oral Solid Dosage Drugs and a Center of Excellence for projects and New Product Introductions (NPIs) relying on flexible manufacturing and testing operations.

The QA Senior Specialist – Quality Projects & Vendors will join the Quality Assurance team of BMS, Switzerland.

This position is responsible for executing the review and approval of all relevant qualification/validation deliverables and other documents required for project implementation associated to the new manufacturing equipment and facility.

Duties/Responsibilities

  • Will provide regulatory compliance support across the end-to-end product lifecycle for validation lifecycle activities associated with equipment qualification, Computerized System Validation (CSV), Cleaning Validation and guidance documents to ensure conformance to applicable industry accepted standards and BMS requirements
  • Participate as Quality Validation representative for site project implementation of new manufacturing equipment, room, utilities and cleaning program.
  • Review and approve qualification and validation documentation (e.g risk assessment, protocol, report).
  • Evaluate, review and approve deviation, discrepancy and change control that occurred during qualification/validation of equipment/systems in his area of responsibility.
  • Support the Data Integrity assessment for new equipment/systems.
  • Review and approve procedures associated with project deployment.
  • Will operate effectively and with minimal supervision, within a team or independently, performing projects and related duties, as assigned.
  • As required, provides QA support to SMEs to ensure the compliance to procedures and industry standards.

Qualifications, Specific Knowledge, Skills, Abilities

  • Good understanding of solid oral dosage form manufacturing/packaging and QC processes
  • Experience with Change Control, Deviation Management and Risk management Quality Systems
  • In-depth understanding of equipment qualification (including automation element), Cleaning validation and Computerized System Validation experience (CSV)
  • Knowledge of most common office software (e.g Microsoft Office word, excel, PowerPoint)
  • Experience in change management during project implementation as well as protocol deviation and discrepancy
  • Experience in risk-based approach to qualification/validation
  • Experience in Data Integrity
  • Good understanding of the drug development process from discovery through to regulatory filing and approval of drug applications as well as commercial manufacturing processes
  • Excellent analytical, interpersonal and communication skills, including written and verbal communication in French and in English
  • Works independently, yet effectively in a team environment
  • Able to deal with ambiguity, to identify and mitigate risks
  • Strong sense of ethics, diplomacy and discretion
  • Strong critical thinking to analyze complex situations and discern critical issues
  • Ability to manage various projects, create and work within internal timeliness, solve problems, deliver on commitments and utilize interpersonal skills in a cross-functional team
  • Excellent team player attitude

Education/Experience/ Licenses/Certifications

  • University graduate (science degree preferred)
  • At least 5 years of experience in Quality Assurance area related to qualification/validation in a pharmaceutical company or other regulated industry.
  • Thorough understanding of cGMPs and Swiss, EU, and FDA regulatory requirements.

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

Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

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 [email protected]. 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.

To apply for this job please visit tnl2.jometer.com.


Job Notifications
Subscribe to receive notifications for the latest job vacancies.