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QA Aseptic Project
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Boehringer Ingelheim
As part of the Quality Stream Aseptic Project structure and reporting directly to the Quality Stream Lead, the QA Aseptic Project will be responsible for supporting decision-making processes related to quality requirements during the design phases of Dispensing, Compounding, Filling (isolator), and auxiliary equipment for the project (Grade C environment).
Tasks And Responsibilities
Support decision-making regarding quality requirements during the design phases of Dispensing, Compounding, Filling, and auxiliary equipment for the aseptic project
Participate in the drafting, review, or approval of documents resulting from decisions made during the project design phases (e.g., rationales, risk analyses)
Review and approve documents related to the qualification-validation lifecycle of production equipment, process and cleaning validations, laboratory equipment, computerized systems, analytical method validations and transfers, utilities, and facilities, in accordance with cGMP, corporate, and local procedures
Ensure cGMP and regulatory compliance (FDA, EMA (Annex I), China, Japan, etc.
) of all associated documents and workflows
Participate in follow-up meetings with Local – Integral functions in order to align key decisions and procedures
Collaborate in the development of new EBR - electronic batch record from the design phases prior to PPQ – Validation through to routine stages in Compounding, Dispensing, Filling, and auxiliary equipment (including Machine Integration)
Requirements
University degree in Chemistry, Biochemistry, Biology, Microbiology, Pharmacy, or an equivalent field
Minimum of 5 years of experience in aseptic processing and APS (Annex I EU GMPs, **** FDA Guidance for Industry, etc.) is essential
Fluent spoken and written English and Spanish is required for participation in global meetings and for understanding, reviewing, and approving project documentation
Desirable knowledge of software such as PAS-X, EWM, SAP, SCADA
Experience with Combination Products (syringe + AI / PEN) is a plus
Proactive individual with strong adaptability, flexibility, fast learning ability, autonomy, and excellent communication and interpersonal skills
We offer flexible working conditions, life and accident insurance, health insurance at a competitive price, investment in your learning and development, and gym membership discounts.
We are an equal opportunities employer and pride ourselves on maintaining a diverse and inclusive culture.
We accept diversity of perspectives and strive to create an integrative environment that benefits our employees, patients, and communities.
Boehringer Ingelheim is a global company that develops innovative treatments that improve the lives of humans and animals.
Founded in **** and family-owned since then, Boehringer Ingelheim takes a long-term perspective.
Today, we have 52,000 employees worldwide who foster a diverse, collaborative, and integrative culture.
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