Associate Specialist, QA Operations

21.01.2020 | Employee | 100%

Associate Specialist, QA Operations

Share This Page Associate Specialist, QA Operations Qlty Assurance Methods Boudry, , Switzerland Full time R1520515_EN 1/20/2020 4:03:35 PM Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis. Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results. The QA Operations Team is committed to actively support the Celgene International II site and other departments to ensure cGMP compliant processes on the Couvet site. This position is responsible for quality assurance (QA) involved primarily with the review of bulk or packaged commercial drug products and maintaining working relationships with QA departments at contract facilities. The position will support QA activities (archiving, deviation, CAPA, OOS, change control,...) on the Celgene international II Sàrl manufacturing site of Couvet. As a member of Quality Operations team, this position will be expected to be reliable source of information and interpretation of quality and cGMP compliance requirements. Furthermore, the position holder is responsible to identify and handle packaging, warehouse, or bulk/QC and cGMP compliance related issues. The position holder may also be asked to support the QA team of Celgene International Sàrl in Boudry. Additional tasks are quality metrics, manufacturing investigation for complaint, release of raw materials for production, risk assessments, aswell as the support of health authorities’ inspections and corporate audits. This position will be working closely with the QA Operations management to identify and handle process quality and cGMP compliance related issues, ensure lean release of finished product or bulk product, raw materials for production, as well as to contribute to process improvement in his/her scope of activity. 2. Skills/Knowledge Required ? At least 1-2 years of experience in Quality Control and/or Quality Assurance in a pharmaceutical company or other related industry. ? BS in science or medically related field. ? Good understanding of cGMPs and Swiss, EU, and FDA regulatory requirements. ? Good understanding of Solid Oral Dosage from packaging, warehousing, or bulk and QC processes. ? Excellent interpersonal, collaborative and organizational skills. ? Works independently, yet effectively in a team environment. ? Strong written & oral communication skills in both French and English. ? Very good investigational and QA problem solving skills, has a keen eye for Quality, makes proposals and facilitate decision when escalation is needed. ? Ability to focus attention to details and to handle multiple tasks while working against pressures of deadlines. ? Collaborative, organisational ? Sense of responsibility, reliability, team spirit, initiative and service. ? Knowledge of most common office software. 3. Duties and Responsibilities a. Supports the design of Master Batch Records for bulk or finished pharmaceutical drug product. b. Is responsible for the review “on the floor” of executed batch records of bulk or finished product. c. Ensures ExBRs and document into the shared drive, and folders. d. Ensure archiving of the documentation for compliance to GMP as appropriate. e. Writes new, revises and makes recommendations for SOP and quality documents for Quality department and supported departments of Couvet manufacturing site. f. Handles deviations, CAPA and change control related to Celgene international II packaging and warehouse or bulk and QC issues as assigned and to ensure the execution / follow up of escalation processes up to both Celgene international and the global level. g. Supports the requests either from the stakeholders as appropriate. h. Handles qualification and validation documentation for QA review of relevant documents / reports (DQ, IQ, OQ, PQ, Cleaning Validation, Process Validation) and supports execution. i. Support during Authorities inspections, audits and visits to external manufacturers/suppliers by participating, when requested. j. Handles complaints and executes investigations as assigned. k. Represents QA within department and cross functional project teams according to assignments. l. Participate to recommendations for continuous improvements in Quality systems as required. m. Contributes of regular reporting of quality processes metrics. n. Ensures that all regulations concerning product security and all established working methods are respected within the area of responsibility. 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 the resources to pursue their goals, both at work and in their personal lives. Working with Us By fostering a culture of inclusion, we empower this 21st century workforce to achieve our company's mission of helping patients to prevail over serious diseases. Explore Job Opportunities A clear purpose. An inclusive culture. The chance to work at the top of your field. These are a few of the reasons Bristol-Myers Squibb is the right choice for your next career move. Come Meet Our Team Are you ready for a career where you make a profound difference? We invite you to visit us at one of our events to learn more. For US Applicants Only Bristol-Myers Squibb endeavors to make this website accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact . This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. The Physician Payment Sunshine Act (Sunshine Act) requires Bristol-Myers Squibb to report any transfers of value, including payments made to reimburse interview-related expenses, for candidates who are US-licensed physicians. U.S. licensed Physicians covered by the Sunshine Act include Doctors of Medicine, Osteopathy, Dentistry, Dental Surgery, Podiatry, Optometry and Chiropractic Medicine who are licensed to practice medicine in the U.S. This information will be reported to the Centers for Medicare and Medicaid Services (CMS) on an annual basis and CMS shall post submitted data on its public database. For more information, Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law. For our EEO Policy Statement, please . If you'd like more information on your EEO rights under the law, please click here: and Follow Us Powered by © 2018 Bristol-Myers Squibb Company

21.01.2020
Employee, 100%

Contact

Bristol Myers Squibb

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Bristol Myers Squibb

Route de Perreux 1Boudry

Industry

Healthcare

Year of foundation

1896

Bristol Myers Squibb

Route de Perreux 1Boudry

Industry

Healthcare

Year of foundation

1896
Salary

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