QA Validation Specialist Job

QA Validation Specialist is needed to perform the following duties :

• Develop, review, and maintain the Validation Master Plan (VMP) to oversee all validation activities.
• Design and execute validation protocols, including equipment qualification, cleaning validation, and process validation.
• Collaborate with cross-functional teams to enhance equipment reliability, performance, and compliance.
• Manage interactions with Original Equipment Manufacturers (OEMs) for equipment qualification, troubleshooting, and optimization.
• Conduct risk assessments and validation studies in line with regulatory expectations and scientific principles.
• Quality Management: Ensure adherence to all applicable Quality Management System (QMS) standards.
• Investigate non-conformances and implement corrective and preventative actions (CAPA) to mitigate quality risks.
• Author and review quality documents, such as Standard Operating Procedures (SOPs) and validation reports.
• Work closely with manufacturing, engineering, and quality assurance teams to coordinate validation activities.
• Provide technical guidance and training to team members on validation techniques and principles.
• Manage project timelines and deliverables related to validation activities to ensure project milestones are met.
• Report on validation status, including challenges and successes, to senior management. Responsible for overseeing all aspects of aseptic validation processes, including technical authoring of validation protocols, equipment commissioning and qualification activities, establishing processes, and developing and conducting qualification studies to ensure equipment and processes consistently meet pre-determined specifications and quality attributes.
• Provide technical support during validation activities like process validation, cleaning validation and sterile validation to assure high quality product manufacturing at the site.
• Leader in change control processes in validating the new or existing products.
• Technical authoring of user-friendly Standard Operating Procedures (SOPs), work instructions, and complex validation protocols in compliance with current FDA regulations. This role also involves designing and delivering effective training to shop floor personnel to enhance their understanding and execution of activities, further ensuring operational excellence and regulatory compliance.
• Provide scientific approach for technical assessments to identify associated risks to the patients due to site operations like manufacturing, testing, packing and distribution of drugs
• Author comprehensive validation documents, ensuring clear, concise, and accurate content that meets regulatory and quality standards.
• Utilize expertise in regulatory environments, quality management systems, and validation protocols to enhance job performance and team capabilities.

Bachelor’s Degree is required in Pharmacy or Drug Regulatory Affairs or Pharmaceutical Science