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Quality Systems Specialist

Bristol Myers Squibb
Dublin, Country: Ireland
Job Type:
Job Description

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.

Bristol Myers Squibb Ireland

Bristol Myers Squibb (BMS) has been in operation in Ireland since 1964, employing over 600 people across a range of activities and business units.

Located in Dublin, Cruiserath Biologics Campus, a one billion Multi-Product Cell Culture Biologics Manufacturing facility, is part of the Global Product Development and Supply (GPS) network. This state of the art facility produces multiple therapies for the company’s growing biologics portfolio and plays a central role in Bristol Myers Squibb global manufacturing network. The Global Biologics Laboratory (GBL) responsible for the release testing of Biologics Drug product for the network, is also based on the Cruiserath Biologics Campus.

BMS Cruiserath has been awarded “Biopharma Company of the Year 2019” in the Irish Pharma Industry Awards and is certified as a Great Place to Work for 2017, 2018 and 2019.

Many of the global business services, including Commercial, the European Treasury Centre, Global Bio Lab and Global Logistics are based on the island of Ireland. Ireland is also home to External Manufacturing’s global headquarters, the organization responsible for the management of manufacturing and reliable supply across the Bristol Myers Squibb global network. This includes management of, and working in conjunction with, third party contract manufacturers and internal manufacturing sites.

The Role

BMS Cruiserath Biologics is seeking to recruit a Quality Systems Specialist on a Fixed-term 9 month contract. Reporting to the QA Systems Manager. The QA Specialist will provide QA oversight and support qualification and validation, technical transfers, regulatory approvals and commercial operations. The role will also support the biologics Drug Substance manufacturing operations through start-up and onto routine commercial operations. In addition, the QA Systems Specialist will support CBQC function responsible for release testing and batch certification for finished drug product.

Key Duties and Responsibilities:

  • Support the administration of Product Quality Complaints (PQC) including processing, and maintenance of site PQC program.
  • Support the QA Documentation systems on site.
  • Support the administration of Change Control system.
  • Support and maintain the Quality Risk Management program.
  • Support of Regulatory and Corporate Inspections.
  • Co-ordination and support of the CAPA system
  • Authoring, review and approval of QA-related procedures.
  • Development of site training curricula, training material and SOPs for the site training program as required.
  • Support Quality Council and Quality Site Metrics generation.
  • Support OPEX programs and champion continuous quality improvement initiatives.

Qualifications, Knowledge and Skills Required:

  • The successful candidate will hold a BSc in Science or related discipline, with a minimum 3 years’ QA experience in a bio-pharmaceutical environment. A clear understanding of cGMP requirements for quality systems and compliance is required.
  • The QA Systems Specialist will be required to work on his/her own initiative in addition to working as part of a team. The candidate must be able to work across a team matrix in order to meet accelerated timelines. Excellent communication & presentation skills are essential.
  • The successful candidate must demonstrate excellent time management & organizational skills along with a proven ability to multi-task.

Whats important to us

Employees are expected to display the BMS Values, which move us toward our mission to discover, develop and deliver innovative medicines that help patients prevail over serious diseases:

  • Passion: Our dedication to learning and excellence helps us to deliver exceptional results.
  • Innovation: We pursue disruptive and bold solutions for patients.
  • Urgency: We move together with speed and quality because patients are waiting.
  • Accountability: We all own BMS’ success and strive to be transparent and deliver on our commitments.
  • Integrity: We demonstrate ethics, integrity and quality in everything we do for patients, customers and colleagues.
  • Inclusion: We embrace diversity and foster an environment where we can all work together at our full potential.

We have a passion for tackling the toughest diseases, which inspires innovation and speed in our daily work and a sense of accountability to the patients we serve.

Why you should apply

  • You will help patients in their fight against serious diseases
  • You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
  • You’ll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical allowance, 23.5 days annual leave plus 3 Company days, life assurance, on-site gym and gain-sharing bonus.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

Job Settings
Number of jobs: 1 hires
Information about the advertiser
Company: Bristol Myers Squibb
Company size: 1-49
Contact: NA