CGxPServe

Roles & Responsibilities: Our client is looking for someone with a minimum of five (5) years experience in capital project equipment delivery coordinating the storage installing start-up de-bugging commissioning and qualification of laboratory related equipment in a cGMP pharmaceutic

Roles & Responsibilities: Our client is looking for someone with a minimum of five (5) years experience in capital project equipment delivery coordinating the storage installing start-up de-bugging commissioning and qualification of laboratory related equipment in a cGMP pharmaceutic

Job Description: The Associate QC Scientist performs laboratory testing within a fast paced GMP environment in support of one or more of the following areas; raw materials in-process product final Bulk product stability and/or validation. Analyzes test data and evaluates results. Writ

Job Description: The Associate QC Scientist performs laboratory testing within a fast paced GMP environment in support of one or more of the following areas; raw materials in-process product final Bulk product stability and/or validation. Analyzes test data and evaluates results. Writ

Job Description: We are seeking an experienced Validation Engineer with strong expertise in SAP and OpenText systems combined with technical writing/documentation skills. This role is critical in ensuring compliance validation and accurate documentation of enterprise applications part

Job Description: We are seeking an experienced Validation Engineer with strong expertise in SAP and OpenText systems combined with technical writing/documentation skills. This role is critical in ensuring compliance validation and accurate documentation of enterprise applications part

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

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

Role & Responsibilities: Develops and Executes Process Validation Strategies Creates plans protocols (IQ OQ PQ) and risk assessments to ensure effective processes for medical devices and equipment. Ensures Regulatory Compliance Adheres to FDA (21 CFR 820) ISO 13485 and other relevant

Role & Responsibilities: Develops and Executes Process Validation Strategies Creates plans protocols (IQ OQ PQ) and risk assessments to ensure effective processes for medical devices and equipment. Ensures Regulatory Compliance Adheres to FDA (21 CFR 820) ISO 13485 and other relevant

Job Description: The role will focus on commissioning qualification and validation (CQV) oversight while ensuring compliance with regulatory standards and internal quality systems. This position requires strong leadership attention to detail and familiarity with computerized maintena

Job Description: The role will focus on commissioning qualification and validation (CQV) oversight while ensuring compliance with regulatory standards and internal quality systems. This position requires strong leadership attention to detail and familiarity with computerized maintena

Responsibilities: The Principal Regulatory Affairs is responsible for regulatory strategy development and execution for high-complexity diagnostics specifically Companion Diagnostics and digital pathology in the clinical oncology environment. The Senior Principal Regulatory Affairs w

Responsibilities: The Principal Regulatory Affairs is responsible for regulatory strategy development and execution for high-complexity diagnostics specifically Companion Diagnostics and digital pathology in the clinical oncology environment. The Senior Principal Regulatory Affairs w

Responsibilities: The Senior Regulatory Affairs Specialist recommends process improvements updates regulatory SOPs and applies broad regulatory knowledge to support compliance across various geographies and submission types. Working under general supervision they contribute to comple

Responsibilities: The Senior Regulatory Affairs Specialist recommends process improvements updates regulatory SOPs and applies broad regulatory knowledge to support compliance across various geographies and submission types. Working under general supervision they contribute to comple

Responsibilities: The Principal SAS Programmer will be responsible for statistical programming for the clients clinical studies. In this role you will develop and validate SAS programs for data presentation analyses and provide programming support to project team members. Our Ideal c

Responsibilities: The Principal SAS Programmer will be responsible for statistical programming for the clients clinical studies. In this role you will develop and validate SAS programs for data presentation analyses and provide programming support to project team members. Our Ideal c

Job Description: Summary of Contractor Engineer Focus on Medical Devices Drug Device Delivery Systems and Combination Products. BS degree as minimum requirements of 1-5 years (MS preferred and PhD acceptable) in the field of biomedical mechanical chemical materials science and en

Job Description: Summary of Contractor Engineer Focus on Medical Devices Drug Device Delivery Systems and Combination Products. BS degree as minimum requirements of 1-5 years (MS preferred and PhD acceptable) in the field of biomedical mechanical chemical materials science and en

Responsibilities: Provide application/system validation expertise for standalone enterprise and integrated systems in a regulated (GxP) environment. Lead OT system qualification and validation including Client/DCS integrated with manufacturing equipment. Support qualification activit

Responsibilities: Provide application/system validation expertise for standalone enterprise and integrated systems in a regulated (GxP) environment. Lead OT system qualification and validation including Client/DCS integrated with manufacturing equipment. Support qualification activit

Responsibilities: Independently perform SAS programming and analysis support of the generation of analysis datasets statistical analysis listings figures and tables. Independently develop SAS application code. Independently perform validation of SAS programs and deliverables. Indepen

Responsibilities: Independently perform SAS programming and analysis support of the generation of analysis datasets statistical analysis listings figures and tables. Independently develop SAS application code. Independently perform validation of SAS programs and deliverables. Indepen

Role & Responsibilities: Masters degree in pharmacy chemistry or related field with 3 years of relevant experience. Support regional regulatory activities for PDM CMC Project and Commercial Teams focusing on Small/Synthetic Molecules. Assist CMC RA leads in risk identification rankin

Role & Responsibilities: Masters degree in pharmacy chemistry or related field with 3 years of relevant experience. Support regional regulatory activities for PDM CMC Project and Commercial Teams focusing on Small/Synthetic Molecules. Assist CMC RA leads in risk identification rankin

Job Description: This position will provide support to ensure the organization maintains compliance with Quality Systems current Good Manufacturing Practices (cGMPs) current Good Tissue Practices (cGTPs) and in adherence with all applicable Federal State local international and indust

Job Description: This position will provide support to ensure the organization maintains compliance with Quality Systems current Good Manufacturing Practices (cGMPs) current Good Tissue Practices (cGTPs) and in adherence with all applicable Federal State local international and indust

Job Description: MES Engineer is responsible for supporting activities such as requirements gathering testing implementation and use of Manufacturing Execution Systems (MES). Position is expected to operate with some supervision and some autonomy. Role will primarily be responsible fo

Job Description: MES Engineer is responsible for supporting activities such as requirements gathering testing implementation and use of Manufacturing Execution Systems (MES). Position is expected to operate with some supervision and some autonomy. Role will primarily be responsible fo

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 information t

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 information t

Responsibilities: Develop implement and maintain quality systems to ensure compliance with industry standards and customer requirements. Collaborate with engineering and production teams to establish and monitor quality control processes. Support new product introductions by developi

Responsibilities: Develop implement and maintain quality systems to ensure compliance with industry standards and customer requirements. Collaborate with engineering and production teams to establish and monitor quality control processes. Support new product introductions by developi

Responsibilities: Plan and execute assigned particle characterization tasks as well as other applicable physical analytical chemistry tasks utilizing standard procedure and technical understanding of various techniques to complete assigned tasks. Independently generate precise reliab

Responsibilities: Plan and execute assigned particle characterization tasks as well as other applicable physical analytical chemistry tasks utilizing standard procedure and technical understanding of various techniques to complete assigned tasks. Independently generate precise reliab

Responsibilities: Develop and implement data management plans for clinical trials. Ensure data quality and integrity throughout the trial. Develop and maintain study-specific data management documents such as data management plans annotated CRFs and database specifications. Collabora

Responsibilities: Develop and implement data management plans for clinical trials. Ensure data quality and integrity throughout the trial. Develop and maintain study-specific data management documents such as data management plans annotated CRFs and database specifications. Collabora

Job description: As a member of the Clients Acute Therapies Verification and Validation engineering team you would be responsible for supporting product verification validation and compliance test activities on electrical and mechanical medical device components/systems. Your expertis

Job description: As a member of the Clients Acute Therapies Verification and Validation engineering team you would be responsible for supporting product verification validation and compliance test activities on electrical and mechanical medical device components/systems. Your expertis