cGxPServe

Responsibilities: Oversee the preparation and review of dossiers and documents ensuring timely renewal of facilities and product licenses in the US Canada and other countries. Monitor regulations by FDA Health Canada COFEPRIS ANVISA and others designing strategies for compliance with More...

Job Description: The contract Lead Engineer Quality Validation will be responsible for providing quality and technical support for qualification and validation activities related to laboratory instruments temperature control units and LFH/BSC units for internal customers. The individ More...

Roles & Responsibilities: Bachelors degree and 03 years experience with HPLC. Perform routine analytical testing to support quality control testing of pharmaceutical products. Some data interpretation required. Coordinate testing of samples and input data into computer application More...

Responsibilities: Design electrical and/or power electronics circuitry for Premium CT Hardware either on NPI products or maintenance of installed base. Drives and is accountable for operational excellence of assigned designs projects and rigor with duties including design project rev More...

Roles &Responsibilities: Reviews prescriptions issued by Physician or other authorized prescriber to assure accuracy and determine formulas and ingredients needed. Directs pharmacy workers engaged in mixing packaging and labeling pharmaceuticals. Answers questions and provides inform More...

Job description: Responsible for performing the accurate and detailed medical review of complex advertising and promotional materials and nonpromotional materials . Provides timely and accurate reviews of promotional materials in accordance with established policies and practice stand More...

Responsibilities: Provide strategic insight to the GRT regarding product development and serve as Regulatory contributor to partner teams (eg study teams clinical development team etc. as appropriate. In collaboration with regional regulatory representatives ensure that feedback More...

Responsibilities: Design and implement portions of the software for new and existing devices working cross functionally to understand needs and requirements and supporting the team with your technical expertise. Take part in the creation of schedules and tasking to facilitate the of More...

Job Description: Perform SCF operations maintaining product quality and production levels. Work as member of a team for maximum effectiveness. Responsibilities include product inspection operating equipment raw material/finished goods movement and cleaning/sanitizing. Monitor machin More...

Responsibilities: Involve in Supplier Issue Resolution. Work on Corrective Actions Implementation Collaborate w/ cross functional team during issue resolution Develop & Propose supplier Improvement Plan. Proliferate Key learnings & Document into BKM wherever applicable. Assist in the More...

Responsibilities: Prepares technical documents to support both domestic and international regulatory submissions. Incorporates text graphs charts tables and statistical analysis. Proofreads circulates edits assembles inspects and duplicates product submissions. 5 years exp. Innovativ More...

Responsibilities: Ensure distribution licenses (where required) accurately reflect the current organization vary license where necessary. Support recalls mock recalls and any other onmarket activity. Serve as QA assessor/approver on Change Controls: resolve gaps approve change plans More...

Job description: The Biologics Drug Product Development team develops antibody drug conjugates (ADC) and other biologics by stateoftheart formulation and analytical technologies. We create valuable intellectual property through new formulation compositions cost effective manufacturing More...

Job Description: The Validation Engineer is responsible for developing DQ/IQ/OQ/PQ protocols and coordinating and performing equipment qualifications ensuring that automated process equipment that mass produce medical device consumables and other products are designed developed or cha More...

Responsibilities: Develop and implement data management plans and procedures for clinical trials. Oversee the collection and validation of clinical trial data. Ensure data quality and accuracy through data review query resolution and data cleaning. Work with crossfunctional teams inc More...

Roles & Responsibilities Review computerized systems validation documents such as: Requirements Specification Design Specification CSV Risk Assessment Test Plans Test Summary Reports Data Migration Plan Pre/Post Executed Test Scripts Traceability Matrix. Release to Production Stateme More...

Job Description: We are seeking an experienced Lead Computer System Validation (CSV) professional to oversee and execute validation protocols for computer systems in a regulated life sciences environment. The ideal candidate will ensure that systems meet regulatory compliance stand More...

Responsibilities: Project Management: Project manage all CAPA activities from initiation to closure ensuring timely and effective . Issue Identification and Assessment: Identify and assess issues ensuring accurate and thorough documentation. CAPA Data Review: Review CAPA data sources More...

Responsibilities: Manage programming activities on project or study level including managing CROs to ensure deliverables are accurate and compliant. Act as a Programming SME for assigned studies including authoring/reviewing programming specifications such as SDTM/ADaM specific More...

Responsibilities: The Principal SAS Programmer independently leads the programming activities for various purposes including CSRs DSMBs interim analyses manuscripts etc. Mainly supports statistical programming of statistical analysis plan (SAP)planned tables data listings and graphs More...