• Lead validation efforts to ensure compliance and quality in contract pharmaceutical manufacturing processes.• Develop and implement validation strategies, protocols, and procedures in line with regulatory requirements (FDA, EMA).• Oversee validation activities for equipment, processes, and systems.• Collaborate with cross-functional teams to maintain compliance and drive continuous improvement.• Utilize strong background in pharmaceutical validation.• Demonstrate keen attention to detail.• Exhibit passion for ensuring product quality and patient safety.

Providing expertise and achieving tangible outcomes in highly regulated FDA industries is a key responsibility. This involves seamless collaboration with cross-functional teams encompassing regulatory affairs, manufacturing, quality control, and quality assurance, thereby fostering innovation and prosperity within the life sciences regulated sector. Offering valuable insights on critical facets such as CSV, CSA, equipment qualification, and process validation. In addition, actively assisting in the ongoing expansion and development of the consulting firm. ● Providing invaluable GxP validation counsel to clients, ensuring compliance with rigorous regulatory standards. ● Leading project management efforts to facilitate client adherence to new regulatory requirements, enhancing their regulatory preparedness. ● Actively contributing to business growth by participating in client acquisition efforts, expanding the firm's clientele. ● Assisting in the recruitment and onboarding of new consultants, strengthening the firm's pool of talent and expertise.

Created and reviewed validation documentation (VPs, IQs, OQs, and PQs). Led validation protocol execution and testing for equipment and processes. Analyzed validation data for accuracy and compliance. Collaborated with cross-functional teams to optimize validation. Managed regulatory agency interactions and provided required documentation. Stayed updated on industry trends and regulatory standards, implementing best practices for process improvement.● Pioneered and established a comprehensive validation program from inception.● Initiated and developed the entire department, contributing to organizational growth.● Played a key role in implementing a robust Quality Management System (QMS).● Successfully prepared the department and company for seamless audits and compliance.● Spearheaded the approval of the 503B facility and product release.● Led comprehensive validation activities in alignment with regulatory compliance and industry standards.● Developed and implemented efficient validation strategies, policies, and procedures following the CQV methodology.● Effectively planned, scheduled, and prioritized validation projects to meet business goals and deadlines.● Proactively addressed validation issues, deviations, and non-conformities, implementing corrective actions.● Provided staff training and guidance on validation principles, processes, and regulations.

Led validation efforts independently, ensuring precise execution. Performed lab instrument protocol tasks meticulously, adhering to established procedures. Assessed and summarized validation activities, ensuring accurate documentation. Communicated project status to management for effective oversight. Managed lab equipment assets, tracked inventory, and coordinated maintenance. Collaborated with external vendors for calibration and repairs, ensuring efficiency. Reviewed calibration documents for accuracy and compliance. Maintained detailed equipment history records, promoting comprehensive tracking. Include new or existing equipment in the asset history program for improved management.● Proactively communicated and delivered GxP results to clients.● Created comprehensive validation documentation, including VP, IQ, OQ, and PQ, ensuring accuracy.● Skillfully coordinated equipment and instrument calibration, maintaining adherence to quality standards.

Reported compliance violations, promoting accountability and continuous improvement. Coordinated CAPAs with upper management, facilitating resolution and corrective measures. Managed controlled documentation, ensuring compliance with regulations. Produced quality and audit reports for informed decision-making. Supported product safety procedures in collaboration with management. Stayed updated on regulatory and corporate requirements for initiative-taking compliance.● Led successful third-party audits, ensuring compliance with regulations.● Executed internal audits, identifying improvement areas, and upholding quality standards.● Provided staff training on guidance, audit readiness, quality, and safety, boosting compliance and knowledge.

Supplied organized data for FDA annual product review submissions, ensuring regulatory compliance. Conducted precise scientific data reviews to maintain integrity and accuracy. Efficiently managed daily operations, prioritizing work, and optimizing resource allocation. Implemented innovative technology and methods for enhanced lab productivity and innovation. Documented and addressed non-conforming materials, initiating corrective actions. Collaborated with suppliers to resolve quality issues and meet standards. Led audits by customers and government agencies, navigating SOPs adeptly● Ensured on-time release of materials and products, maintaining efficiency and quality.● Oversaw and actively engaged in FDA audit preparedness, promoting regulatory compliance.● Orchestrated and executed continuous improvement projects, driving process enhancements.

Developed and reviewed equipment validation procedures, ensuring comprehensive and accurate documentation. Led multistep improvement projects, promoting continuous enhancement and process optimization. Created and executed validation protocols, technical documents, and final reports for documentation of validation activities and results.● Validated equipment, including autoclaves, ovens, and environmental chambers, following industry standards.● Authored and executed IQ, OQ, and PQ protocols, ensuring equipment performance validation.

Managed maintenance, repair, and calibration of lab equipment in production, quality control, and R&D labs. Maintained records, qualifications, and documentation using Calibration Manager software, ensuring accessibility and completeness.● Enhanced instrument availability by implementing timely calibration practices, reducing downtime and costs.● Standardized operational processes by developing and revising SOPs for both new and existing instruments.

Performed microorganism, fungal, and pollen identifications for quality control and risk management. Applied knowledge of GLP and cGMP, ensuring regulatory compliance. Utilized data integrity guidelines, USP standards, and FDA/USDA regulations to maintain data reliability. Conducted quality testing, including microscopic and macroscopic identifications, viability testing, moisture testing, and bioburden testing, ensuring product safety. Authored deviations and investigations, facilitating root cause analysis and corrective actions.● Proficient in strict clean room gowning techniques and maintaining contamination control.● Mastered endotoxin level determination through specific laboratory tests.● Acquired comprehensive knowledge and proficiency in accurate sterility testing for product safety.● Expert in precise microorganism quantification through filtration and bioburden testing.