Key Responsibilities. Regulatory Submissions. Assist in the preparation and submission of regulatory documents, including new product applications, amendments, supplements, and annual reports to regulatory authorities. Documentation Management. Maintain and organize regulatory files and records, ensuring that all documentation is accurate, complete, and up-to-date. Regulatory Research. Conduct research on current regulations, guidelines, and stan...
Job Summary. The incumbent is responsible for analytically supporting the Quality Control activities from raw materials to the finished product. These activities will include but not be limited to raw material/components testing, setting up instruments for testing, physical testing, stability testing, and finished product. Job Responsibilities. Verifying compendial methods. Analytical support for the QC functions and manufacturing. Calibration of...
Job Summary. The Documentation Control Supervisor is responsible for overseeing the document control process, ensuring that all company documentation is managed, organized, and maintained in compliance with internal standards and regulatory requirements. This role involves supervising a team of document control specialists, coordinating with various departments to facilitate document workflows, and implementing and improving document control syst...
Job Responsibilities. Gains and uses qualifications to perform process steps as necessary to support continuous operations, in accordance with Batch Record manufacturing instructions and current labor standards in order to safely and efficiently manufacture a quality product. Operates the BFS filling equipment through setup, startup, production, and cleaning. Ensures proper setup of the equipment extruder, parison, moulds, etc. during startup and...
Job Summary. Responsible for providing technical assistance and support for incoming queries and issues related to computer systems, hardware or software. Plan, design, develop, implement and maintain applications and related integration for enterprise solutions. Provide expert insight into related application and infrastructure activities to meet customers needs. Job Responsibilities. Respond to highly complex and unconventional queries from ext...
Description. The Aseptic Cleaner will be responsible for daily, weekly and overnight sanitization of the clean room manufacturing areas. The position will also ensure that the detail, scheduling, and methods of cleaning are in compliance with regulations for maintaining the sterility of the clean rooms. Essential functions. Maintains a aseptic environment in the cleanroom, by gowning, cleaning the room, and behaving according to clean room proced...
Job Summary. Reporting to the Sr. Director, Global Quality, the Director, Quality & Compliance is responsible for the Quality function at the AVEVA Tamarac manufacturing facility. The Director, Quality & Compliance has oversight over all GxP activities and functions including Quality Manufacturing & Release, Quality System, Quality Control ,Microbiology, Compliance and Risk Management. Quality organization is an independent function and is respon...
Job Summary. Manage the development and execution of the Yellow, Green Belt and Black Belt Certification. Responsible for supporting change by leading, enabling and supporting the identification and quantification of continuous improvement opportunities where Lean methodology can be applied to successfully transform organizational culture and deliver business results. Drive waste reduction and increase productivity both Site wide and cross-functi...
Job Title. TrackWise/Salesforce Digital Administrator. Location. Aveva, DDS Miramar FL. Position Type. Full-Time. Company Overview. Aveva, DDS Miramar FL is a leading pharmaceutical organization specializing in pharmaceutical manufacturing. We are committed to innovation, quality, and customer satisfaction. We are seeking a highly motivated Salesforce Administrator & TrackWise Digital Administrator to manage and optimize our CRM and quality manag...
Job Summary. Responsible for ensuring root cause analysis is conducted on investigations for Aveva in a timely and efficient manner. Ensures established procedures are followed for all investigations and corrective and preventative actions are implemented. Acts as quality technical resource and reviews all investigation reports for completeness and acccuracy, and compliance. The Lead Investigator position requires the ability to handle a variety ...
This position is responsible for lead the supply chain team and over see the end-to-end supply chain planning for commercialized finished goods products, integrating with R&D, new product launches, post-launch projects, and Opex projects to support process optimization. The role involves executing the tactical planning horizon (0-12 months) for commercialized products, analyzing customer forecasts, and ensuring supply and demand dynamics are cons...
Job Summary. Assists in the inspection and packaging of Avevas transdermal products and clinical labeling of developmental products, and occasionally leads a packaging team. Job Responsibilities. On a temporary or emergency basis fills in as packaging section leader. Inspects commercial transdermal products during packaging. Operates packaging equipment. Cartons finished product. Cleans packaging and production areas and equipment and documents i...
