Senior Quality Assurance Validation Specialist

Overview

• The Senior Quality Assurance Validation Specialist ensures compliance with validation lifecycle requirements in biopharmaceutical manufacturing.
• Collaborate with diverse teams to support validation activities and regulatory adherence.
• Provide expertise in analytical instrument qualification and computer system validation processes.
• Contribute to developing and reviewing validation protocols and risk assessments.
• Support manufacturing operations through audits and compliance evaluations.
• Ensure adherence to FDA and EMA regulations, maintaining high-quality standards.
• Work onsite to provide hands-on validation support and documentation expertise.
• Utilize organizational and technical writing skills for effective validation documentation.

Key Responsibilities & Duties

• Review and approve validation protocols, reports, and specifications.
• Conduct periodic reviews and data integrity assessments for manufacturing operations.
• Evaluate validation lifecycle documents, including risk assessments and qualification protocols.
• Provide expert guidance in cross-functional project meetings.
• Ensure compliance with SOPs, quality standards, and regulatory requirements.
• Support continuous improvement initiatives within validation processes.
• Maintain detailed documentation of validation activities and decisions.
• Provide regular updates on project progress and resource utilization.

Job Requirements

• Bachelor’s degree in Engineering, Microbiology, Chemistry, Biochemistry, or related field.
• Minimum of 2 years of experience in GMP operations within biopharmaceutical industries.
• Proficiency in analytical instrument qualifications and computer system validation.
• Knowledge of FDA and EMA regulations in validation processes.
• Strong technical writing and communication skills with attention to detail.
• Ability to manage multiple priorities and lead complex projects.
• Experience with continuous improvement efforts in validation practices.
• Analytical approach to problem-solving and decision-making.