cGxPServe

Roles & Responsibilities: Hands on experience with AWS Cloud migration testing. Hands on experience in Database and migration testing strategies. Must have life sciences and GxP application testing experience. Experience in handling large programs with multiple applications. Must be المزيد...

Roles & Responsibilities: The Validation Specialist carries out quality control checks on engineering project work under the supervision of the Validation Lead Automation Lead and Project Manager. Perform initial CSV at client site for systems including DeltaV Historian MES ABB as we المزيد...

Job Description: The Senior Validation Engineer will serve as a subject matter expert in validation leading critical projects in support of GMP-compliant manufacturing and product development. This role involves strategic planning execution and continuous improvement of validation pro المزيد...

Job Description: The Senior Quality Engineer is responsible to represent the quality engineering function to develop and execute the strategy to organize direct and report on all supplier quality-related activities for design and manufactured items made for the AST stapling business المزيد...

Responsibilities: Conduct statistical programming and analysis of clinical research studies. Provide programming support for publication efforts and regulatory submissions. Manage the timely creation review completion and delivery of statistical programming activities and deliverable المزيد...

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...

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...

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: 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...

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...