cGxPServe

Job Description: The purpose of the Validation Engineer (contract position) is to complete assignments in support of Quality and Engineering for equipment qualification new product development process validation and test method validation. The successful candidate will assume respons المزيد...

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 المزيد...

Roles & Responsibilities: Will be responsible to work in a team atmosphere on the production of medical equipment spare parts and accessories in accordance with quality specifications. Works within clearly defined SOPs and adheres to quality guidelines. High school diploma or equival المزيد...

Roles & Responsibilities: A minimum of four (4) years of relevant work experience. Hands on production line experience with validations. NC/CAPA root cause analysis FMEAs NPI Design Control Supplier Quality medical device. Someone already experienced with J&J would be preferred for q المزيد...

Responsibilities Support the end-to-end clinical data management process for assigned studies from protocol review to database lock. Collaborate with cross-functional teams including clinical operations biostatistics and medical writing to define data collection and reporting needs. المزيد...

Responsibilities: Shire Human Genetic Therapies Inc. is seeking a Senior Validation Engineer with the following duties: Write Validation documents per Food Drug Administration (FDA)/Company guidelines; draft Specification documents and Validation Plans (VPs) for pharmaceutical manufa المزيد...

Job Description: The Manufacturing Services Associate I is responsible for supporting all cGMP manufacturing production suites. They support the production groups by ensuring the suites are appropriately stocked with raw materials and consumables assemble and autoclave assemblies for المزيد...

Responsibilities: Perform specialized level work assignments and/or analyses evaluation preparation and submission of documentation for the worldwide regulatory registration ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory a المزيد...

Responsibilities: Develop implement and maintain software quality assurance processes for non-product software used in medical device development. Ensure adherence to regulatory standards (FDA ISO 13485 IEC 62304) and industry best practices for non-product software. Support audits a المزيد...

Responsibilities: Ensures that statistical deliverables (tables figures listings) and study datasets (SDTM ADaM) are programmed and validated in accordance with standards requirements of regulatory agencies Sponsors and SOPs. Assesses study datasets and resolves deviations from CDISC المزيد...

Responsibilities: The Regulatory Affairs Associate with minimal guidance prepares reviews and submits high quality annual reports with FDA within Annual report timelines and in accordance with regulatory guidelines and applicable federal laws. With minimal guidance ensure to compile المزيد...

Responsibilities: Responsibilities include developing regulatory strategies reviewing design input/output documentation identification of applicable standards and guidance documents performing regulatory assessments to determine the impact of design/process changes preparing regulato المزيد...

Job Description: The C&Q (Commissioning & Qualification) QA Floor Representative will provide direct quality oversight of commissioning and qualification activities for equipment utilities and facilities supporting pharmaceutical and combination product manufacturing. This role ensur المزيد...

Responsibilities: Lead and manage clinical data management activities for oncology clinical trials ensuring adherence to project timelines budgets and quality standards. Provide strategic oversight and direction to CRO clinical data management teams for assigned studies. Develop and المزيد...

Responsibilities: Technical expert that will independently investigate identify develop and optimize new methods/ techniques to address critical project needs. Continuously seek to improve existing laboratory methods and processes. Read and adapt literature to accomplish assignments. المزيد...

Job Description: We are seeking an experienced and dynamic Senior NPI/NPD Project Manager to lead and execute new product introduction (NPI) and new product development (NPD) projects from concept through launch. This role requires strong cross-functional collaboration meticulous plan المزيد...

Job Description: We are seeking a dedicated MES Support Specialist to provide 24/7 shop floor support including nights and weekends. This role is critical in supporting MES (Manufacturing Execution System) operators resolving incidents in real-time and ensuring uninterrupted productio المزيد...

Job Description: Bioresearch Centre is seeking a dedicated and talented full-time contractor for the position of Biologist I or II to join the Immunology Discovery Dermatology team. The role involves the design and execution of in vitro and ex vivo pharmacology experiments aimed at de المزيد...

Job Description: CSV Analytical and Enterprise Validation specialist IV will lead validation activities including but not limited to software updates new system introduction Administration of systems and applications and decommissioning activities as appropriate. Roles & Responsibilit المزيد...

Responsibilities: Provides leadership/expertise in day-to-day statistical programming in support of ongoing projects. Develops and/or validates SAS programs to generate SDTM/ADaM datasets following industry standards regulatory requirements and statistical instructions. Develops and/ المزيد...