GMP Quality Validation

Responsibilities: Project Planning: Develop comprehensive project plans for validation activities, outlining scope, timelines, resources, and deliverables. Collaborate with cross-functional teams to ensure alignment with project goals. GMP Compliance: Ensure all validation processes adhere to GMP guidelines and other relevant regulatory standards. Stay...

Job DescriptionJob DescriptionDiscGenics is a privately-held, clinical stage biopharmaceutical company focused on developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases of the spine. Summary:  The Validations Engineer will fill an important need at DiscGenics through helping the company...

Job DescriptionJob DescriptionDiscGenics is a privately-held, clinical stage biopharmaceutical company focused on developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases of the spine. Summary:  The Validations Engineer will fill an important need at DiscGenics through helping the company...

GMP Manufacturing Associate Day Shift Kelly Science is looking for a GMP Manufacturing Associate to join a leading biopharmaceutical company in Oklahoma City, OK. Job Responsibilities: Execute and monitor GMP manufacturing processes for cell culture-based production, ensuring compliance with protocols and regulations. Perform routine tasks like media prep,...

Job DescriptionEurofins Lancaster Laboratories, a nationally recognized laboratory, is searching for a QC Analyst to support our Professional Scientific Services group in Foster City, CA. GMP Analyst responsibilities include, but are not limited to, the following : Support GMP testing activities by routinely performing appearance, thermogravimetric...

The Sr. Software Validation Specialist role is an exempt level position with responsibilities for providing quality oversight over the validation and qualification activities for computer systems and processes to support both clinical and commercial requirements in a GXP environment. This role with develop CSV gap assessments and remediation plan with an...

Job Description The Sr. Software Validation Specialist role is an exempt level position with responsibilities for providing quality oversight over the validation and qualification activities for computer systems and processes to support both clinical and commercial requirements in a GXP environment. This role with develop CSV gap assessments and remediation...

Job DescriptionJob DescriptionDiscGenics is a privately-held, clinical stage biopharmaceutical company focused on developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases of the spine. Summary:  The Senior Validations Engineer will fill an important need at DiscGenics through helping the...

Job DescriptionJob DescriptionDiscGenics is a privately-held, clinical stage biopharmaceutical company focused on developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases of the spine. Summary:  The Senior Validations Engineer will fill an important need at DiscGenics through helping the...

Job Description Job: Validation Lead (CSV, Clinical Systems) Location:NJ/PA(Hybrid) Mandatory Skills: CSV, Computer System Validation, Clinical Systems, periodic review and audit experience Roles and Responsibilities: We are looking for a pure validation resource 8 + years Experience in Validating GxP applications Experience in FDA and/or Global regulated...

Job Description Job: Validation Lead (CSV, Clinical Systems) Location:NJ/PA(Hybrid) Mandatory Skills: CSV, Computer System Validation, Clinical Systems, periodic review and audit experience Roles and Responsibilities: We are looking for a pure validation resource 8 + years Experience in Validating GxP applications Experience in FDA and/or Global regulated...

Group Leader, Quality Assurance, Manufacturing Position Summary: Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier...

Group Leader, Quality Assurance,Manufacturing Position Summary:Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives....

About the job SAP Validation Lead Job Requirements: This position is responsible for leading and performing activities in support of creating and maintaining GxP (GMP, GCP, GLP) quality and compliance environment for SAP S/4 HANA. This position is also responsible for monitoring Computer System validation (CSV) as well as compliance with GxP regulations and...

Responsibilities : Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution. You should have excellent understanding of CFR Part , ICH standards, EMA and FDA (GxP) regulations, and GAMP methodologies. Coordinate with...

About the job SAP Validation Lead Job Requirements: This position is responsible for leading and performing activities in support of creating and maintaining GxP (GMP, GCP, GLP) quality and compliance environment for SAP S/4 HANA. This position is also responsible for monitoring Computer System validation (CSV) as well as compliance with GxP regulations...

Support of creating and maintaining GxP (GMP, Google Cloud Platform, GLP) quality and compliance environment for SAP S/4 HANA Perform GxP and 21 CFR part 11 assessments and develop validation planDevelop functional risk strategy and perform functional risk assessmentReview user business process documents and user requirements specificationReview functional,...

Job Description Create qualification documents and perform qualifications on special purpose machines Ensure that commissioned work package is met in terms of deadline, cost and quality Independent project management in the area of qualification and updating of project status for capacity planning and reporting purposes Independent coordination...

Responsibilities:Validation Lead with 10+ years of experience to with Lab Vantage LIMS implementation team who would be responsible for :Planning and implementation of validation projects for Compliant GxP Computerized Systems, particularly for Lab Vantage LIMS systemCreation, Review and in-time delivery of the Validation documentation but not limited to the...

Responsibilities: This position is responsible for leading and performing activities in support of creating and maintaining GxP (GMP, GCP, and GLP) quality and compliance environment for SAP S/4 HANA. This position is also responsible for monitoring Computer System validation (CSV) as well as compliance with GxP regulations and 21 CFR Part 11. Leads...