7 Sterile Injectables Jobs

Responsibilities: Manage DP process activities for sterile injectables. Execute and review sterilization validation procedures. Prepare and review technical documents and reports. Support audits, technology transfer, and process improvements. Requirements: 67 years’ experience in DP process for sterile injectables. Strong knowledge of sterilization validation and regulatory requirements. Skilled in technical documentation. Interest in transitioning to regulatory affairs.

Position Summary The Manufacturing Manager/Senior Manager will provide technical, documentation, and quality system support to on-site manufacturing operations. This role involves managing manufacturing documentation, monitoring performance metrics, driving process improvements, and coordinating with cross-functional teams to ensure seamless execution of production activities in alignment with cGMP standards. Key Responsibilities Documentation & Quality System Support Provide end-to-end documentation support from the India team and work virtually with the on-site U.S. team. Initiate and review Change Controls , Deviations , and CAPA within the Quality Management System (QMS). Prepare and rev...

Key Responsibility: Analytical Data Review Review and verify data from chemical and microbiological analysis for raw materials, in-process samples, finished products, and stability studies Ensure data integrity and compliance with cGMP and regulatory standards Approve Certificates of Analysis (CoA) for final product release Quality Management System: Conduct and review investigations related to laboratory incidents, out-of-specification (OOS), and out-of-trend (OOT) results Identify root causes and recommend corrective and preventive actions (CAPAs) Oversee the closure of laboratory deviations and ensure effective documentation Trend Analysis and Reporting Review and analyze quarterly trends...

Key Responsibility: Manufacturing Oversight: 1. Shop Floor Oversight: Monitor and oversee sterile injectable manufacturing activities on the shop floor to ensure adherence to cGMP, SOPs, and regulatory requirements Provide real-time guidance and decision-making during production to ensure product quality and compliance 2. Batch Manufacturing Record (BMR) and Batch Packaging Record (BPR) Prepare, review, and approve BMRs and BPRs to ensure accurate documentation and compliance with manufacturing procedures Ensure completeness, accuracy, and timely review of all manufacturing records 3. In-Process Quality Checks: Perform in-process quality checks during manufacturing stages to ensure critical ...

Key Responsibility: Validation Activities: 1. Media Fill Studies: Plan, execute, and review media fill trials to ensure aseptic process integrity. Analyze results and recommend corrective actions when necessary. 2. Area Qualification: Oversee qualification of classified manufacturing areas (Grade A-D). Perform routine re-qualifications and environmental monitoring to ensure regulatory compliance. 3. Equipment Qualification: Develop and execute protocols for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of manufacturing equipment. Review and approve qualification documents. 4. Utility Qualification: Validate critical utilities such as HVAC...

Job Summary: Responsible for leading all Quality Control (QC) activities for sterile injectable products. This includes ensuring cGMP compliance, timely testing of materials and products, method validations, and lab readiness for audits and inspections. Key Responsibilities: Oversee day-to-day QC lab operations for sterile injectables (raw materials, in-process, finished product, and stability samples). Ensure compliance with cGMP, regulatory guidelines (USFDA, MHRA, EMA), and internal quality standards. Review and approve SOPs, methods (STP, GTP), specifications, protocols, and validation/transfer documents. Manage method validation, verification, and transfers for drug substances, products...

Job description Experience & Skills required: Experience in new development / product life cycle management associated with regulatory function. Well versed with product development / Manufacturing and sterility assurance, deficiency management. Well versed with labelling requirements. Well versed with eCTD operations. Experience in handling drug device combination products. Good written and verbal communication. Markets: US / EU - Majorly. Experience required: 5-9 yrs in sterile formulations - US market. Qualification: M.Pharmacy