Provide quality, timely and accurate analysis, design, configuration, and support; including daily technical support to end users. Configure process flows for development, testing, and production environments in accordance with approved protocols and scripts. Provide project management for the implementation of new and/or revised processes within the electronic QMS. Maint

Directs and provides expert knowledge in the strategic function of EH&S. Develops short and long term people and organizational strategy in alignment with Aji Bio Pharma goals and direction. Leads with impact & influence. Establishes credibility, effectively persuades and develops others, and achieves important objectives collaboratively. Identifies, recruits, and retains

Together, Let's Make A Difference. At Ajinomoto Bio Pharma Services, our mission is to help improve the health of humankind. As a leading, global contract development and manufacturing organization, with sites in the US, Belgium, Japan and India, we work together to empower our clients to bring drugs to market. Every team member, from manufacturing and quality programs to

Provides leadership, development and management skills in building a cohesive team of talent acquisition professionals ensuring their added value to the candidate care experience and interactions with hiring managers. Leads diversity recruiting strategies to attract a diverse workforce to the company by hiring talented people of varied backgrounds, experiences and styles.

Author and /or revise all client specific Batch Records for both clinical and commercial use. Technical review of client batch record. Ensure technical review of Non GMP records are approved and then sent to client for billing. Work with validation teams from both Aji Bio Pharma and our client to author PPQ Batch Records for clients applying for commercial use of their dr

Responsible for performing validation documentation preparation and review for manufacturing process, equipment, and utilities in accordance with relevant guidance documents and current industry best practices. Executes validation protocols. Writes validation and qualification summary reports. Assists in the setup and execution of autoclave, depyrogenation oven, and steam

Responsible for performing validation documentation preparation and review for manufacturing process, equipment and utilities in accordance with relevant guidance documents and current industry best practices. Executes validation protocols. May be tasked with training lower level personnel. Acts as Validation subject matter expert for regulatory and client audits. Partici

Perform routine analysis and testing in a GMP environment May participate in qualification/verification of assays Assay and documentation review and report writing Maintain personal training records. Attend all required training. May be responsible to provide training as applicable. Regular and reliable attendance on a full time basis [or in accordance with posted schedul

Performs various manufacturing tasks including sterile filtration, formulation, in process testing, and preparation of formulation components, and product development project preparations in accordance to established Standard Operations Procedures (SOP's) and cGMP regulations. Support with the implementation of production and manufacturing procedures and schedules. Effect

Performs various routine manufacturing tasks under the guidelines of established Standard Operating Procedures (SOP's) and cGMP regulations. Coordinates the implementation of production and manufacturing procedures and schedules. Performs visual inspection of tanks and bulk drug substances. Prepares components, media, buffers, and other solutions as needed. Accurately doc

Perform sanitization duties in the cleanroom while aseptically gowned. Accurately record and complete documentation as required, including logbooks and forms in compliance with SOP guidelines. Remove and collect all used disinfectant solution waste and place in the appropriate disposal unit. Administrative tasks including attendance of regularly scheduled departmental mee

Leads to identify, analyze, and evaluate risk management plans following Quality Risk Management process per ICH Q9, collaborates with Subject Matter Experts (SME) for technical input, maintain the Risk Register, and tracks deliverables to closure Leads implementation and improvement of the Data Integrity Program as the Data Integrity Officer, ensures compliance to the Da

Participate as an internal audit team member for inspection readiness preparation Prepare submissions of license applications and renewals. Track and maintain licenses and company submissions as required by applicable regulatory agencies. Collect, collate and evaluate data for routine internal and customer regulatory reports. Maintain current knowledge base of existing an

Design and implement reliability programs to improve uptime. Participate in design and installation stage of projects for new assets and modification of existing assets. Evaluate existing systems for continuous improvement opportunities. Provide technical support to manufacturing, maintenance and other technical personnel. Provide in depth technical review of all document

Design, and implement reliability programs to improve uptime. Evaluate existing systems for continuous improvement Provide in depth technical review of all documents and reports Research new technologies and implement new/upgraded systems Document changes to systems per change management procedures Travel between facilities to support all functional areas Advanced knowled