Katalyst Healthcares & Life Sciences
Job Description: Perform operations maintaining product quality and production levels. Work as a team member for maximum effectiveness. Responsibilities include product inspection, operating equipment, raw material/finished goods movement and cleaning /sanitizing. Monitor machine functions and attempt to detect any conditions…
Responsibilities : Supporting core Quality Systems activities (SOP revisions, inspection readiness, metrics). Developing and improving regional Quality System SOPs. Analyzing quality and risk metrics and escalating gaps as needed. Supporting projects across the Quality Systems function and partnering with site…
Roles & Responsibilities: Must have at least 10 years of experience Must be bilingual (English/Spanish) Someone that can generate VMP, develop systems lists, provide all necessary plans for front end CQV planning documents along with scheduling. Then successfully lead a…
Job Description: The Category Buyer is responsible for Capex Process Equipment procurement activities for Lonza USA sites of approximately $10m to $500m. The Category Buyer is responsible for all assigned procurement activities related to process equipment for projects across North…
Summary : Plan, lead, and execute the validation efforts for SCADA, Rockwell Factory Talk, PLC's and Ignition Create/write validation documentation (VP/URS/FS/DS/Trace Matrix/Risk Assessment/IQ/OQ/PQ, etc.) for process control systems. Author documents related to GxP Systems Draft Requirements and computer systems validation…
Job Description: Implement, control and coordinate changes in documentation. Facilitates the updating and routing of controlled documents, including, but not limited to, Governance and Procedure documents, Master Forms and Master Batch Records within the eDMS. Review documents, review document change…
Responsibilities: Following the Study Data Tabulation Model (SDTM) Implementation Guide, writes specifications for SDTM datasets. Following statistical analysis plans and the Analysis Data Model (ADaM) Implementation Guide, writes specifications for analysis datasets. Following specifications, develops algorithms and writes programs to…
Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules These submissions include health authority briefing packages, IND/CTA, NDA, and MAA regulatory filings. Prepare and review CMC submission documents, registration dossiers, health authority briefing packages and responses…
Summary: Join our team as a Lead IT/Software Validation (CSV) and lead validation activities for GxP compliant IT/software systems. Ensure compliance with corporate SOPs and optimize validation processes. Roles & Responsibilities: • Lead validation activities for GxP compliant IT/software systems…
Job Description Summary: The CSV Specialist is responsible for planning, coordinating, and executing validation activities for computer systems to ensure compliance with regulatory requirements. This role involves working closely with IT, Quality Assurance, and business stakeholders to validate new and…
Roles & Responsibilities: Lead and manage validation activities for LIMS and MES implementations, upgrades, and integrations. Develop and review Validation Master Plans (VMPs), Validation Protocols (IQ, OQ, PQ), and Test Scripts in compliance with GAMP 5 and company policies. Oversee…
Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules. These submissions include health authority briefing packages, IND/CTA, NDA, and MAA regulatory filings. Prepare and review CMC submission documents, registration dossiers, health authority briefing packages and responses…
Job Description: Responsible for supporting Process Chemistry and Engineering operations within the Pharmaceutical Products Group API at Client Lake County. The Lab Manager will work directly with organizing laboratory spaces, managing chemical and equipment inventories, and assisting department chemists in…
The Regulatory Affairs Associate will be responsible for managing, authoring, and compiling Chemistry, Manufacturing, and Control (CMC) sections of regulatory submissions for marketed product variations, including Class III implantable medical devices. This position involves coordinating cross functional activities to ensure…