This position will provide QA technical support for External Manufacturers (EM) European, Latin America or North America Region. Review and approve quality system documents including SOP, specification and manufacturing instructions.
Responsible for product release, ensuring products meet cGMP specifications and regulatory requirements. Provide QA support for technology transfer and improvement of existing manufacturing processes. Contribute to the overall development, implementation and execution of quality systems in support of to ensure complaint, product quality and product safety. Conduct investigations, perform GMP audits, collect data, analyze trends, and prepare management reports as required. Responsible for continuous improvement and risk management activities of EM.
Key Responsibilities:
• Reviewing batch documentation and product release
• Conducting and participating in manufacturing investigations.
• Reviewing and approving EM deviations
• Developing corrective action plans and monitoring implementation
• Review and approve change control
• Writing and implementing of quality procedures
• Identifying and implementing continual improvements of manufacturing and quality/compliance processes
• Assess current process and systems and recommend improvements to enhance reliability and reduce cycle time
• Analyzing product quality complaints and assisting the external manufacturer to complete complaint investigation
• Participating in quality audits at external manufacturers
• Monitor quality trends, identify issues, recommend and implement appropriate actions to mitigate risk.
• Participate and support escalation process and issue management process
• Support regulatory inspections, manage JJRC reporting and monitor follow up on regulatory commitments
• Maintain Quality Agreement and specification changes. Qualifications - External
Education
• A Bachelor's or equivalent University degree is required with a focus in engineering, science or equivalent technical discipline preferred.
Experience and Skills: Required:
• Demonstrates knowledge of Quality Assurance, Quality Control and Compliance
• A minimum of 6 years relevant work experience
• Ability to provide cGMP compliance support to contract manufacturers by investigating and resolving quality issue
• Experience in applying process excellence tools and methodologies
• Proficient in written and spoken English Preferred:
• Experience in the development, implementation, and review of SOPs for interactions with contract manufacturers
• Advanced degrees in engineering, science, or an equivalent technical
• Experience investigating customer Product Quality Complaints
• Experience in pharmaceutical / biologics manufacturing or quality environment
