Validation Consultant

at  Katalyst Healthcares Life Sciences

Responsibilities:

• Validation Planning and Strategy: Develop and implement validation plans and strategies in alignment with current Good Manufacturing Practices (cGMP), FDA, EMA, and other regulatory guidelines.
• Commissioning, Qualification, and Validation (CQV): Lead and execute CQV activities for manufacturing equipment, facilities, and processes, ensuring they meet predefined specifications and quality attributes.
• Installation Qualification (IQ) and Operational Qualification (OQ) : Perform IQ and OQ activities, ensuring equipment and systems are installed and functioning according to manufacturers’ specifications and industry standards.
• Performance Qualification (PQ) and Process Performance Qualification (PPQ): Oversee PQ and PPQ to demonstrate that processes operate in a state of control and meet product quality specifications.
• Protocol Authoring and Execution: Develop, review, and execute validation protocols and reports, including but not limited to, risk assessments, test scripts, and validation summaries.
• Change Control and Deviation Management Manage change control processes and investigate deviations from established processes or outcomes, implementing corrective actions as necessary.
• Collaboration and Coordination Work closely with cross-functional teams, including engineering, quality assurance, manufacturing, and regulatory affairs, to ensure alignment of validation activities with project goals.
• Regulatory and Quality Compliance Ensure all validation activities and documentation comply with regulatory requirements and quality standards, preparing for and supporting regulatory inspections and audits.

Requirements:

• Bachelor’s degree in Engineering, Science, or related field.
• Extensive experience in validation within the pharmaceutical or biotechnology industry, with a focus on sterile manufacturing.
• Strong understanding of cGMP, FDA, EMA, and other regulatory requirements.
• Proficient in the principles and practices of process validation, equipment qualification, and cleaning validation.
• Excellent analytical, problem-solving, and decision-making skills.
• Exceptional communication and collaboration abilities to work effectively with all levels of the organization and cross-functional teams.
• Ability to manage multiple projects and priorities in a fast-paced environment.

• Validation Planning and Strategy: Develop and implement validation plans and strategies in alignment with current Good Manufacturing Practices (cGMP), FDA, EMA, and other regulatory guidelines.
• Commissioning, Qualification, and Validation (CQV): Lead and execute CQV activities for manufacturing equipment, facilities, and processes, ensuring they meet predefined specifications and quality attributes.
• Installation Qualification (IQ) and Operational Qualification (OQ) : Perform IQ and OQ activities, ensuring equipment and systems are installed and functioning according to manufacturers’ specifications and industry standards.
• Performance Qualification (PQ) and Process Performance Qualification (PPQ): Oversee PQ and PPQ to demonstrate that processes operate in a state of control and meet product quality specifications.
• Protocol Authoring and Execution: Develop, review, and execute validation protocols and reports, including but not limited to, risk assessments, test scripts, and validation summaries.
• Change Control and Deviation Management Manage change control processes and investigate deviations from established processes or outcomes, implementing corrective actions as necessary.
• Collaboration and Coordination Work closely with cross-functional teams, including engineering, quality assurance, manufacturing, and regulatory affairs, to ensure alignment of validation activities with project goals.
• Regulatory and Quality Compliance Ensure all validation activities and documentation comply with regulatory requirements and quality standards, preparing for and supporting regulatory inspections and audits