Responsibilities

We are looking for a highly organised and detail-orientated Quality Specialist to join our team based on a customer site in Macclesfield, UK. This role will be an integral part of our on-site Quality team, ensuring that our service delivery complies with agreed quality commitments, regulatory requirements, and our quality management system.

Key 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.

Essential Skills:

• Strong analytical, problem-solving, and organisational skills.

• Excellent communication and interpersonal skills.

• Thorough understanding of Good Documentation Practices (GDP).

• Knowledge of regulatory requirements for GMP/GLP/GCP activities.

Essential Qualifications:

• Bachelor's 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

• Recognized Quality Management qualification.

• Strong understanding of quality standards and methodologies (e.g. ISO 9001, Six Sigma, LEAN)

Desirable Qualifications:

• Certified Quality Auditor or similar certification.

• Knowledge of GMP regulatory requirements.

• Experience of working within the pharmaceutical sector.

Working Environment:

• This is a site-based role at a customer location.

• The position requires work in laboratories and controlled environments, where the use of personal protective equipment (e.g., lab coat, safety glasses, etc.) is required.  

• The role may involve fast-paced tasks and high job demands.  

• The person needs to occasionally move between labs, corridors, adjoining rooms, and buildings onsite.

• 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.