Responsibilities

• As part of the onsite team, provides routine support and guidance to ensure service delivery is in compliance to our agreed quality and regulatory standards
• Working with identified SME’s, supports with the writing of technical documentation ensuring high quality content and adherence to GMP standards.
• Provides guidance for the inspection readiness program for the site, while ensuring compliance to our scope of work and defined requirements within the QMS and Quality agreement.  Inspection readiness may include periodic PerkinElmer or client self-inspections, or any external agency inspections
• Works with the quality team and operations team providing support to the deviation, change, event & root cause investigation processes, ensuring effective and on-time completion of CAPA management.
• Support the vendor management program for the site to ensure adequate supplier compliance, while ensuring adherence to the QMS for the scope of work defined in the SLA and/or Quality Agreement. 
• Develop and implement training and education programs, to educate PKI employees and management on quality processes, standards and results
• Support with the development and implementation of an annual quality plan based upon areas for continuous improvement of our quality service.  
• Work closely with procurement, engineering and other departments to ensure supplier-related quality issues are addressed promptly.
• Participate in cross functional teams to drive quality improvement initiatives.
• Prepare and present reports on quality performance and audit findings to management.
• Support with the delivery of the program quality improvement plan

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities of this job at any time.

Critical Skills:

• Excellent analytical, problem-solving, and organisational skills.
• Strong communication and interpersonal skills
• Strong understanding of Good Documentation Practices
• Understanding of regulations governing GMP/GLP/GCP activities

Basic Qualifications:

• Bachelors degree in quality management, supply chain management or a related field OR

• Minimum of 3 years experience in quality assurance, supplier management, or a related role. OR
• Recognised Quality management related qualification OR
• Strong knowledge of quality standards and methodologies (e.g. ISO 9001, Six sigma, LEAN)

Preferred Qualifications:

• Certified quality auditor or similar certification
• Knowledge of regulatory requirements relating to GMP
• Experience of working within Pharma

Working Environment:

• Role is site based on a customer site.
• Must be able to work in a laboratory, controlled environments requiring personal protective equipment (e.g., lab coat, safety glasses, etc.) in laboratory. 
• Job pace may be fast and job completion demands may be high. 
• Must be able to remain in a stationary position more than 25% of the time 
• The person needs to occasionally move between labs, corridors, adjoining rooms, and buildings onsite Frequently operate on instruments, objects, tools or controls, which will require regularly bending, squatting, stretching and reaching in order to perform in a service function.   
• Specific vision abilities required by this position include without limitation, the ability to observe details at close range distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus in order to perform the essential service functions of this position.   
• Operates a computer and other office machinery, such as a calculator, copy machine, and computer printer. 
• May be required to complete Medical Clearance, Respiratory Protection Training, and Fit Testing to wear a respirator as protection against hazards present in the laboratory environment.