Senior Pharmaceutical Validation Specialist IV/OV/PV Expert
United Pharma Technologies Inc
We are seeking an experienced Senior Validation Specialist to support validation activities for a leading pharmaceutical manufacturing client. This role will focus on executing and documenting validation efforts across Installation Verification (IV), Operational Verification (OV), and Performance Verification (PV) protocols. The ideal candidate will have a strong background in pharmaceutical validation, regulatory compliance, and technical documentation. Key Responsibilities Execute and support validation activities, including IV, OV, and PV protocols. Author and review validation documentation, including: Validation Plans Project Quality Master Plans Change Requests Validation Summary Reports Other qualification and validation documents Support the AP Validation Area, including: Formulation Equipment Filling Operations Inspection Equipment Ensure validation activities comply with company procedures and applicable regulatory requirements. Perform root cause investigations and implement corrective actions for validation-related issues. Develop technical documentation using equipment manuals, engineering drawings, and manufacturer specifications. Collaborate with cross-functional teams to support project timelines and quality objectives. Required Qualifications Bachelor's degree in Engineering, Life Sciences, or a related technical field (or equivalent experience). 7+ years of validation and/or quality experience within the pharmaceutical industry. Hands-on experience with equipment qualification and validation documentation. Strong knowledge of pharmaceutical regulations and industry standards, including: 21 CFR Part 11
GAMP 5
FDA regulations ICH guidelines ISO standards Electronic records and data integrity requirements Experience conducting root cause analysis and implementing effective corrective actions. Proven ability to author and review technical documentation based on equipment manuals and engineering documentation. Excellent written, verbal, and interpersonal communication skills. #J-18808-Ljbffr United Pharma Technologies IncVacancy posted 1 day ago
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