Aseptic Manufacturing Specialist

Aseptic Process Engineer/Lead plays a crucial role in Qrc Group Llc’s operations, overseeing the design and support of aseptic manufacturing processes at designated facilities. Key responsibilities include planning, execution, tracking, and completion of key projects related to production process/systems implementation, shut down/restart process, media...

Aseptic Process Engineer/Lead to design and support the aseptic manufacturing processes at designated locations. Responsible for supporting the planning, execution, tracking, and completion of key aseptic related projects such as but not limited to: Production process/systems implementation, shut down/restart process, media fill oversight, deviation...

The successful Aseptic Process Engineer/Lead will be responsible for providing technical support to formulate, aseptic filling, and sealing operations. Additionally, they will lead and support aseptic process simulations, conduct and write formal investigation reports with assistance from plant personnel, and ensure thorough understanding of GMPs and aseptic...

Regulatory Consultant will provide expert guidance and support in navigating the regulatory landscape, specifically in aseptic production environments.Responsibilities: Provide expert regulatory advice for aseptic manufacturing processes, ensuring compliance with FDA and global regulatory standards.Prepare and review regulatory submissions to the FDA,...

**Job Overview:**We are seeking a highly skilled Regulatory Consultant to join our team at Qrc Group Llc. This individual will provide expert guidance and support in navigating the regulatory landscape, specifically in aseptic production environments.### Responsibilities:Provide Regulatory Advice: Offer expert regulatory advice for aseptic manufacturing...

Project Manager to lead and manage projects in the aseptic areas, particularly in the development, validation, and FDA submission processes for pharmaceutical and medical device products.Responsibilities:Develop project timelines, resource allocation plans, and budgets, ensuring timely and on-budget delivery.Coordinate and oversee all stages of project...

CSV specialist to perform validation activities on software and manufacturing equipment in a medical device industry.Skills:Computer system validation life cycle.Knowledge and experience validating software and medical devices equipment.Technical writing (English).Requisitos:Bachelor in Science 5 years of experience Experience in the medical devices...

We are looking for a Senior Manager of Pharmaceutical Projects to join our team at Qrc Group Llc.Job Summary:Lead and manage projects related to the development, commissioning, and validation of aseptic pharmaceutical productsKey Qualifications:PMP certified preferableStrong knowledge of FDA regulations (CFR Part 210/211, 21 CFR Part 820), aseptic...

At Qrc Group Llc, we are seeking a highly skilled Data Validation Specialist to join our team.About the role:The successful candidate will be responsible for performing validation activities on software and manufacturing equipment in the medical device industry.Key skills and qualifications include:Computer system validation life cycleValidation of software...