cGxPServe

Responsibilities: Creates Computer System Validation (CSV) deliverables (Validation Plan Requirements Specifications Protocols Summary Reports Trace Matrices SOPs Risk assessments). Collaborates with Business Users System Owner Global IT teams and Business Analysts to define valida More...

Roles & Responsibilities: Develop and execute validation protocols for computer systems. Ensure compliance with regulatory requirements and industry standards. Create detailed validation documentation including plans reports and scripts. Conduct risk assessments and impact analyses r More...

Roles & Responsibilities: Minimum eight to ten 810 years of experience in EHS at an operational facility including five 5 years experience with relevant technical subject matter. Must have significant experience managing and implementing EHS programs at operational sites on a tactica More...

Job Description: We are seeking a skilled and experienced Validation Consultant with a strong background in the pharmaceutical industry particularly in decommissioning of facilities equipment and systems. The ideal candidate will work closely with crossfunctional teams to ensure c More...

Responsibilities: This position requires a solid understanding of clinical trials data integration and programming techniques to support the creation validation and of clinical study data in a fastpaced environment Illuminate Platform Expertise: Utilize the Illuminate platform to su More...

Roles & Responsibilities: Quality Engineering is responsible for product and service quality evaluation and control. Works crossfunctionally in the development and or maintenance of products or services. The Engineer is involved in resolving the equipment and processrelated productio More...

Roles & Responsibilities: Responsible for the efficient and effective performance of testing in conformance with regulations and standards. Responsibilities include inspection analysis of results determining final disposition of some product and detecting nonconforming conditions. Wo More...

Responsibilities: Develop comprehensive technical documentation including user manuals installation guides labeling materials and regulatory documentation for ophthalmic devices. Work closely with engineering regulatory and quality teams to ensure all documentation meets industry s More...

Roles & Responsibilities: Perform Safety certification test assessments throughout the development lifecycle including early stages to provide the necessary inputs to R&D to drive product development. Support development including planning communicate periodic status and known risks More...

Roles & Responsibilities: Uses a variety of equipment such as forklifts conveyers cranes handcarts and power trucks to move materials parts assemblies and finished products or goods within a plant office or warehouse. May maintain records. Develops skills in basic tasks techniques an More...

Responsibilities: Responsible for tooling documentation. Altering existing drawings. Replicating tooling. Releasing tooling into the quality system. Requirements: 3 years of tooling experience. Strong Solidworks experience. Medical device industry background. Any foundry or casting More...

Responsibilities: Manufacturing Engineer required to support existing and future implant medical device manufacturing lines and systems. Orthopedic Implants Manufacturing Machinery experience such as Precision Machining Techniques Design for Manufacturing (DFM) Assistance Foundry CNC More...

Roles & Responsibilities: Proven leadership in testing/validation for medium to large system implementations ensuring GxP compliance and quality delivery. Extensive experience with Waterfall Iterative and Agile methodologies guiding teams to successful project outcomes. Proficient i More...

Responsibilities: When you join us you will work with a team of committed individuals who trust each other to deliver on the tasks at hand. We support innovation and outofthebox thinking balanced with collaboration across functions and other teams. Our leadership understands the nee More...

Responsibilities: Lead projects with higher level of complexity/challenges/difficulties. Lead efforts to resolve complex statistical programming issues or problems. Perform a leadership role in statistical programming projects by coordinating study team(s) overseeing timelines assign More...

Responsibilities: Checks claims in advertising and promotional documents against published sources before projects are submitted for medical/regulatory/legal review. Ensures that suitable references are used to support all product and promotional claims in text graphs charts tables a More...

Responsibilities: Has detailed operational knowledge of the equipment to the point that he/she can operate within specified quality/quantity limits. Sets up and debugs equipment to the specifications listed in specifications plant policies and Department Procedures. Deviations from More...

Job Description: Setup operate optimize changeover/troubleshoot and maintain assigned departmental production equipment. Responsible for meeting/exceeding production standards maintaining product quality minimizing/preventing equipment downtime and sustaining budgeted waste levels on More...

Job Description: Review and approve Qualification protocol. Work with MSAT in the development of protocols based on changes made on the SMPs and MPRs . Assist in investigation and resolving discrepancies and errors during the testing. Review the package of the qualification proto More...

Job Description: The client needs someone with Facilities CQV experience including EMPO Vessel IOV and IOPQ including mixing and temp mapping. They have personnel assigned to Utilities (WFI Alcohol N2 Compressed Air etc. CIP Filter Press Centrifuge CIP skids and Cleaning Validation; t More...