13 Cgmps Jobs

Role Overview: You will be supervising the labeling and packaging of medical devices in a controlled environment. This will involve overseeing the packaging of products in blister or pouches. Your responsibilities will include creating and modifying labeling for finished products, ensuring adherence to design and branding guidelines. Collaborating with various departments to address labeling inconsistencies and meet project objectives will be an essential part of your role. Managing labeling change requests within the document management system will also be a key responsibility. Key Responsibilities: - Ensure all activities comply with cGMPs - Write/update SOPs related to department activiti...

As a part of the Technical Operations department at Azurity Pharmaceuticals, your role will involve overseeing technical process strategy, managing contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs), and ensuring the delivery of product objectives in alignment with company policies and client requirements. You will be responsible for leading teams, collaborating cross-functionally, and achieving project milestones to support process scale-ups, validation, technical transfers, post-approval changes, and investigations for commercial products. **Principal Responsibilities:** - Manage the planning and execution of manufacturing activitie...

Role Overview: As a Production Operator in the granulation department, your main responsibilities will include: Key Responsibilities: - Operate, clean, and perform primary maintenance on negative isolator, Vibro sifter, Bin blenders, and all other GEA granulation line equipment. - Record activities in logbooks, Batch manufacturing record, and complete documentation following cGMPs and good documentation practices. - Perform all in-process checks and monitoring of intermediate processes in granulation. - Select recipes, set process parameters in Blender HMI, and ensure correctness before blender revolution. - Issue, utilize, clean, and retrieve sieves and handle machine change parts with inve...

As a member of the Technical Operations team at Azurity Pharmaceuticals, you will play a crucial role in managing and overseeing technical process strategy, CMO and CDMO management, and the execution of product deliverables. Your dedication and expertise will contribute to the success of Azurity in providing innovative products to underserved patients. Here are the key responsibilities and qualifications required for this role: **Key Responsibilities:** - Manage the planning and execution of manufacturing for both development and commercial products, including qualification and validation activities. - Develop, review, and approve controlled documentation related to late-stage development, q...

Tris Pharma, Inc. is a leading biopharmaceutical company with a focus on developing and commercializing innovative medicines to address unmet patient needs in areas such as ADHD, spectrum disorders, anxiety, pain, and addiction. With over 150 US and International patents, we market branded ADHD products in the U.S. and license our products globally. Our robust pipeline of innovative products spans neuroscience and other therapeutic categories, driven by our unique science and technology. At Tris Pharma, our team members are the heart of our success. We value a culture of passion, innovation, and collaboration. We believe in respectful, open, and honest communication to support individual and...

At Lilly, we are dedicated to uniting caring with discovery to enhance the lives of people worldwide. As a global healthcare leader based in Indianapolis, Indiana, we strive to bring life-changing medicines to those in need, advance the understanding and management of diseases, and contribute to our communities through philanthropy and volunteerism. Our priority is always people, and we are seeking individuals who are committed to improving lives across the globe. As a Shift Supervisor for Environmental Monitoring (EM) Technicians at our Indianapolis Parenteral Plant, your role involves providing supervision to ensure compliant customer service to production operations. You will oversee rout...

As a Manager - Corporate Quality Audit at Sun Pharmaceutical Industries Ltd, you will be responsible for overseeing the Gamma Irradiation of Sun Pharma products at third-party gamma irradiation sterilization sites. Your primary role will involve supervising the sterilization process, monitoring the irradiation of batches, and ensuring compliance with quality assurance regulations and auditing techniques. Key responsibilities include: - Demonstrating a sound understanding of pharmaceutical manufacturing processes for both non-sterile and sterile formulations. - Supervising the Gamma sterilization site used for sterilizing drug products and components. - Monitoring the receipt and dispatch of ...

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company dedicated to developing innovative products to serve underserved patients. With a focus on providing unique, accessible, and high-quality medications, Azurity continuously expands its commercial product portfolio and late-stage pipeline by leveraging integrated capabilities and a vast partner network. The company's patient-centric offerings span various markets including cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, positively impacting millions of patients. As an inclusive workplace and Equal Opportunity Employer, Azurity attributes its success to a team of talente...

The role involves supervising the labeling and packaging of medical devices in a controlled environment. This includes overseeing the packaging of products in blister or pouches. You will be responsible for creating and modifying labeling for finished products, ensuring adherence to design and branding guidelines. Collaborating with various departments to address labeling inconsistencies and meet project objectives is an essential part of the role. Managing labeling change requests within the document management system is also a key responsibility. Ensuring that all activities comply with cGMPs and writing/updating SOPs related to department activities are crucial aspects of the position. Yo...

The core job responsibilities for the position holder include: Responsible for operating, cleaning, and performing primary maintenance on negative isolator, Vibro sifter, Bin blenders, and all other GEA granulation line equipment. This includes recording activities in logbooks, Batch manufacturing records, and completing documentation required for product manufacturing and equipment cleaning, while following cGMPs and good documentation practices. Performing all in-process checks and monitoring of intermediate processes in granulation. Selecting recipes and setting process parameters in Blender HMI, ensuring correctness before blender operation. Issuing, utilizing, cleaning, and retrieving s...

As a Manufacturing Process Engineer in the Pharma Solutions sector, you will be the subject-matter-expert providing real-time process engineering support to the manufacturing process at our facility in Lexington, Kentucky. Your primary responsibilities will include designing, project managing, and implementing new and existing systems, utilities, and equipment to ensure Quality, Compliance, and improved OTIF for all products produced. You will report directly to the Engineering Manager and work on Continuous Improvement Projects, providing technical expertise in specifying, installing, troubleshooting, and maintaining systems, equipment, and processes. Additionally, you will support day-to-d...

The core job responsibilities of the position holder include: Responsible for the operation, cleaning, and primary maintenance of negative isolator, Vibro sifter, Bin blenders, and all other GEA granulation line equipment. Record activities in logbooks, Batch manufacturing record & complete documentation following cGMPs and good documentation practices. Perform all in-process checks and monitoring of intermediate processes in granulation. Select recipes, set process parameters in Blender HMI, and ensure correctness before blender revolution. Issue, utilize, clean, and retrieve sieves and handle machine change parts with inventory. Set up, changeover, and operate various manufacturing equipme...

Skill required.. •Accomplish ITQM objectives in the assigned project by planning, executing and evaluating quality activities (as per service description). Accountable that assigned projects implement security and compliance with applicable laws/regulations like CSV, NVS Standards, the IMF, and project methodology Hands-on experience in Regulatory Compliance (UK DPA, SOX, PII, Data Privacy & Security etc.). Should be able to liaison with the client information security, compliance & legal teams on regulatory requirements & facilitate evidence provisioning during audits • Experience in implementation of at least 2 complete cycles of Information Security Management Systems. Good understanding ...