| GxP Validation Consultant for Pharma Client | Onsite - Boston | 10+yrs at Boston, Massachusetts, USA |
| Email: [email protected] |
| Hi Team, Role : GxP Validation Consultant for Pharma Client Location : Onsite - Boston YoE: 10+yrs Location: [Specify Location or Remote] Job Type: [Full-time/Part-time/Contract] About the Role: We are seeking a highly skilled and experienced GxP Validation Consultant to support our pharmaceutical client. The ideal candidate will have a strong scientific background coupled with extensive experience in GxP (Good Practice) validation processes, particularly in the pharmaceutical industry. Key Responsibilities: Lead and execute validation activities in compliance with GxP regulations, including GMP (Good Manufacturing Practice), GCP (Good Clinical Practice), and GLP (Good Laboratory Practice). Develop, review, and approve validation protocols (IQ/OQ/PQ), standard operating procedures (SOPs), and validation reports. Ensure all validation processes meet the requirements of FDA, EMA, and other regulatory agencies. Provide expert guidance during regulatory inspections and audits to ensure compliance. Collaborate with cross-functional teams, including quality assurance, manufacturing, and IT, to ensure successful validation project execution. Maintain up-to-date knowledge of industry standards, guidelines, and best practices related to GxP validation. Identify and troubleshoot validation-related issues, proposing and implementing effective solutions. Qualifications: Scientific Background: A degree in a relevant scientific discipline (e.g., Chemistry, Biology, Pharmacy) is required. Experience: Proven experience in GxP validation within the pharmaceutical industry. Hands-on experience with validation of processes, equipment, and computer systems is essential. Regulatory Knowledge: Strong understanding of FDA, EMA, and other global regulatory guidelines related to GxP. Technical Expertise: Proficient in developing and executing validation protocols (IQ/OQ/PQ) and SOPs. Communication Skills: Excellent written and verbal communication skills, with the ability to produce clear and concise validation documentation. Problem-Solving: Strong analytical and problem-solving abilities with a detail-oriented approach. Preferred Qualifications: Previous experience in GxP validation activities. Certification in quality management or GxP-related areas (e.g., ASQ Certified Quality Auditor, Certified Validation Professional). -- Thanks, Suba Sales Executive San Antonio, TX https://www.linkedin.com/company/urbanzo-tech/ www.urbanzotech.com This email may contain Urbanzo Tech confidential information and is intended only for use by those to whom it is addressed. If you are not the intended recipient, please contact the sender and delete all copied of the message. Thank You! -- Keywords: information technology Texas GxP Validation Consultant for Pharma Client | Onsite - Boston | 10+yrs [email protected] |
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| Fri Aug 30 00:36:00 UTC 2024 |