Validation Specialist

3 weeks ago

Lexington, Kentucky, United States Oxford Global Resources Full time
Job Summary:

As a Validation Consultant at Oxford Global Resources, you will play a critical role in ensuring the quality and compliance of our pharmaceutical products. Your primary responsibility will be to develop and execute cleaning, process, and packaging validation plans and protocols. You will also be responsible for writing final summary reports that summarize executed qualifications/validations. Additionally, you will assist in the development, coordination, and execution of qualifications/validation protocols for systems governed by federal regulations as applicable in the pharmaceutical industry. You will coordinate validation-related activities in regards to equipment and processes being deployed in GMP environments.

Key Responsibilities:

• Develop and execute equipment qualification protocols for all manufacturing, processing, and packaging equipment and facilities/utilities supporting these operations
• Develop and execute process validation protocols for all manufacturing and packaging processes of commercial products (and R&D products as applicable)
• Develop and execute cleaning validation/verification protocols for all commercial and R&D manufacturing, processing, and packaging equipment
• Perform proper and timely sampling of in-process/intermediate products, finished products, rinse water, and surface swabbing for testing as outlined by validation/qualification protocols
• Perform physical testing from representative samples
• Analyze data, utilizing statistical methods, generated by validation studies performed by the Validation group to determine process capabilities
• Gather photocopies and compile relevant documentation such as executed batch records, certificates of analysis, equipment logs, equipment qualifications, raw material certificates of analysis
• Investigate and resolve deviations/exceptions from the predefined acceptance criteria
• Draw conclusions from data, observations, deviation/exception, and investigation as to whether process is considered valid
• Write Summary reports (closeout report when applicable) for validation/qualification protocols following criteria as outlined within the validation/qualification procedures and policies
• Maintain protocols and system documentation in an orderly library so that information can be provided to regulatory bodies in a timely manner
• Ensure protocols, verification, validation plans, and Summary reports generated during validation/qualification activities are stored according to procedure
• Maintain current knowledge in the areas of compliance and validation and other regulatory issues that may impact the Company
• Work proactively to maintain the highest level of compliance in all areas
• Gather current knowledge from QA/QC, regulatory, periodicals, and/or appropriate training programs
• Interact and coordinate compliance efforts with other departments including, but not limited to, Operations, Engineering, QA, laboratories (QC and R&D), and R&D to provide a high degree of assurance that all qualification/validation activities, where appropriate, are completed
• Adhere to all cGMPs, compliance/regulatory mandates, and quality requirements
• Perform other related duties as assigned to meet departmental and Company objectives

Requirements:

• Knowledge of FDA regulated biotechnology or drug validation requirements including knowledge of FDA 21 CFR Parts 210 and 211
• Knowledge of Analytical Balance, LOD Instrument, Micrometer, Friabilator, Hardness Tester, Calculator, Particle Size Analyzer, Disintegration Apparatus, Viscometer
• Knowledge of Statistical software and calculations
• Knowledge of manufacturing processes, sampling techniques, government regulations, and guidelines pertaining to those areas
• Knowledge of SCADA control system
• Strong understanding of cGMPs and validation/qualification concepts
• Ability to read, program, troubleshoot PLC Ladder Logic, and HMI software
• Ability to analyze pharmaceutical processes to determine critical parameters and critical quality attributes and design testing in the form of protocols to ensure robust and repeatable process
• Must have in-depth knowledge of equipment set-up and operation, facility qualifications, master validation policies, and protocol generation, and protocol execution
• Ability to perform qualification and validation reporting
• PC proficiency using Microsoft Office suite
• Excellent written and verbal communication skills
• Highly organized and detailed
• Ability to read and comprehend written technical procedures, as-built drawings, P&IDs, blueprints, as well as cGMP and SOPs
• Ability to accurately perform mathematical calculations required by work assignments
• Bachelor's degree in Chemistry, Pharmacy, Engineering, or related Science; or equivalent combination of Bachelor's degree and pertinent, progressive experience in pharmaceutical or other highly regulated industry
• Three years proven experience in validation, with particular knowledge of 21 CFR Part 210 and 211
• Experience in 21 CFR Part 11 desired

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