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 – Global 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, 2004 FDA Guidance for Industry, etc.) is essential.
- Fluent spoken and written English and Spanish is required for participation in general 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.
#IamBoehringerIngelheim because…
We are continuously working to design the best experience for you. Here are some examples of how we will take care of you:
- Flexible working conditions
- Life and accident insurance
- Health insurance at a competitive price
- Investment in your learning and development
- Gym membership discounts
If you have read this far, what are you waiting for to apply? We want to know more about you
We would like to inform you that your application will be processed, but the contact from the recruitment team will not take place before September. We appreciate your understanding and patience.