Senior Specialist QA Compliance

21.01.2020 | Employee | 100%

Senior Specialist QA Compliance

Share This Page Senior Specialist, QA Compliance Qlty Assurance Methods Boudry, , Switzerland Full time R1520514_EN 1/20/2020 4:03:33 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. Competences QA Compliance is committed to actively support Celgene Boudry and Couvet manufacturing sites and other departments to ensure cGMP compliant processes on both sites. 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 and Couvet manufacturing sites. The position holder will be responsible for the assigned processes and activities within QA Compliance team. The activities include responsibility for execution of the main following processes: internal audits, annual product review reporting, product quality complaints and supplier’s qualification. Additional tasks are the support of health authorities inspections and corporate audits, monitoring of regulatory changes, response to regulatory authorities requests, QA oversight on contract manufacturing / testing partners, reporting of quality processes metrics, deployment and execution of annual GMP training. The QA Compliance Sr Specialist can be assigned special tasks in cross-functional projects to support Boudry and Couvet manufacturing sites activities like introduction of new product on the manufacturing site. As a member of the Quality Operations department, this position will be working closely with the QA Compliance management to identify and handle process quality and cGMP compliance related issues. Skills/Knowledge Required At least 5 years of experience in a pharmaceutical company or other related industry, ideally in Quality Assurance. BS in Science or related field. Very good understanding of cGMPs and regulatory requirements. Good understanding of solid oral dosage form manufacturing processes and QC testing methods are preferred. Excellent interpersonal, collaborative and organizational skills. Works independently on routine tasks, makes decisions for minor issues. Ability to focus attention to details. Very good written & oral communication skills. Very good investigational and QA problem solving skills. Knowledge of most common office software (Microsoft Office). Duties and Responsibilities Manages internal audits program by planning, executing self-inspections and following-up on action plans. Supports the supplier qualification process by assisting in material supplier and vendor evaluation and approval. The position holder may participate in external audits as Celgene audit team member, QA liaison or subject matter expert (SME). Provides support for vendor and supplier contract setup and modification, as needed. Is responsible to handle deviations, CAPA and change controls related to suppliers. Generates annual product reports for products made on Boudry and Couvet manufacturing sites. Supports the product quality complaints process by handling complaints, executing investigations as assigned and acts as a delegate of QA Compliance Sr Mgr for complaints close-out. Manages preparation and execution of authorities inspections and corporate audits in different roles (i.e. back office, subject matter expert, note taker or runner) for Boudry and Couvet Sites. Performs QA oversight of assigned contract manufacturing / testing partners as assigned. Informs on regulatory changes and coordinate assessment and action plans with SMEs. Provides response related to regulatory authorities requests, e.g. in the scope of submission or periodic GMP review. Contributes of regular reporting of quality processes metrics for different review meetings Supports the deployment and execution of GMP training intended for all Boudry and Couvet manufacturing sites departments involving GMP activities. Ensures the representation of QA within department and cross-functional project teams according to assignments. Assists with writing SOPs and makes recommendations for SOP revisions for the Quality Operations and supported departments of Boudry and Couvet manufacturing sites. Acts as deputy for colleagues within QA Compliance team. Can be assigned “ownership” of QA Compliance processes, including coordination of day to day activity, maintenance of associated documentation, participation of process enhancement and training of new users. 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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