Key Responsibilities:

• Lead Quality Investigations: Conduct thorough quality investigations within sterile/aseptic manufacturing environments, identifying root causes and implementing corrective actions.
• Execute CQV Activities: Oversee and execute Commissioning, Qualification, and Validation (CQV) activities for equipment, systems, and processes in sterile/aseptic facilities.
• Thermal Mapping: Perform and manage thermal mapping to ensure compliance with regulatory and industry standards for temperature control and monitoring.
• Sterilization/SIP Processes: Support and enhance Sterilization/SIP processes, ensuring all procedures meet the required standards for aseptic environments.
• Regulatory Compliance: Ensure all CQV activities comply with regulatory requirements, including GMP, FDA, and other relevant industry standards.
• Cross-Functional Collaboration: Work closely with cross-functional teams, including Quality Assurance, Operations, and Engineering, to resolve quality issues and drive continuous improvement initiatives.
• Documentation and Reporting: Prepare detailed reports and documentation related to CQV activities, including validation protocols, test results, and corrective actions, ensuring adherence to Good Documentation Practices (GDP).
• Risk Assessment: Conduct risk assessments and identify potential areas of improvement to optimize processes and enhance product quality.

Client Requirements:

• Experience: Minimum 8+ years of experience in quality investigations, specifically within sterile/aseptic environments.
• CQV Expertise: Demonstrated experience in Commissioning, Qualification, and Validation (CQV), with a particular focus on sterile/aseptic facilities.
• Thermal Mapping: Proven expertise in performing and overseeing thermal mapping processes is essential.
• Sterilization/SIP: Experience in Sterilization/SIP processes is highly desirable.
• Regulatory Knowledge: In-depth understanding of industry standards and regulations, including GMP, FDA, and other regulatory guidelines for sterile manufacturing environments.
• Problem-Solving Skills: Strong analytical and problem-solving abilities, with a focus on resolving complex quality issues.
• Collaboration: Strong interpersonal and communication skills, with the ability to work effectively in cross-functional teams.

Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or a related field.
• Proven track record of success in CQV roles within sterile/aseptic manufacturing environments.
• Strong knowledge of thermal mapping, sterilization/SIP, and quality investigation processes.
• Familiarity with regulatory standards such as GMP, FDA, and other relevant guidelines.