Seeking an experienced CMC Writer / Project Manager to support regulatory submissions and ensure timely, high-quality documentation for global health authorities. This role combines technical writing expertise with project management skill...
Summary The Product Quality Engineer (PQE) display basic understanding of the Product Engineering and Quality Management System concepts. Utilizes sound statistical and engineering techniques/tools to investigate non-conformances. As Quali...
Responsibilities: Lead and manage full lifecycle of capital projects, including planning, budgeting, execution, and closeout, ensuring alignment with site and corporate goals. Oversee engineering activities for projects including but not...
Responsibilities: Performs routine production functions including filling, utility operations, packing, packaging, assembling, labeling and inspecting under general supervision. Maintains accurate records and logs in accordance with FDA ...
Responsibilities: Responsible for the manual inspection, labeling, and packaging of clinical and commercial products. Perform finished product packaging as required to satisfy all customers, internal, clinical, and other demands. Ensure ...
Summary : Tools sets experience JIRA Confluence Micro Focus ALM (Client ALM)MS office Must have Experience Should have solid Validation Testing lead experience working for pharmaceutical companies. Should have great communication, drive f...
Summary We are seeking a highly skilled and detail-oriented Supplier Quality Engineer to join our team. The ideal candidate will have a strong background in medical device supplier quality, with hands-on experience in supplier qualificatio...
Job Description: We are seeking an experienced Validation Specialist to support validation activities for Syringe Assembly Machines (SAM) in a GMP-compliant pharmaceutical environment. The ideal candidate will possess a strong understandi...
Responsibilities: Effectively manage and oversee statistical programming resources including contractors and CROs related to statistical programming deliverables to ensure high-quality within timeline and budget. Conduct hands-on validat...
Responsibilities: Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses. Responsible for filing necessary applications and handling all government interactions pertaining to the regulatio...