Overview: element has an opportunity for an experienced quality specialist to join our rapidly growing life sciences groupThe quality specialist – gmp/glp will support the testing quality function across the element life sciences laboratories, manage customer, accreditation and regulatory body relationships and drive standardization and best practice in gmp/glp quality systems and processes, lead a culture of quality excellence, in addition to mentoring, training and further building the quality management team and operational gmp/glp teamsThis role reports into quality director, life sciences.
Element’s life sciences group supports developers and manufacturers in the antimicrobial, food and nutraceutical, medical device, and pharmaceutical and biotechnology industriesWe provide personalized testing solutions and regulatory consulting support to validate the safety and efficacy of our clients’ products at every stage of development, production and market releaseResponsibilities:
Develop and ensure compliance with element quality system and processes and perform internal audits related to the gmp/glp scope of testing services
Provide quality support and gmp/glp expertise to operational and divisional management and location quality managementSupport in audit preparation and post audit activity implementation
Support the quality director, life sciences planning and execution strategy to drive standardization of gmp/glp quality techniques and technologies, quality and technical processes and procedures and advise on their continuing suitability based on industry experience and customer expectations
Promote the quality specialist – gmp/glp role as the subject matter expert within element and identify technical specialists (“go to colleagues”) for the various gmp/glp activities and establish an effective internal network
Ensure through personal continued professional development that changes in the technical, quality and regulatory landscape relating to gmp/glp testing activities are anticipated and processes adjusted accordingly
Effectively desk review procedures to prepare gmp/glp sites for 24/7/365 site audit readiness for all customers, regulatory agencies, and quality system accreditation (e.gIso 17025) with detailed pre-audit reports as required by internal qms and other assessment bodies
Skills / qualifications:
10-15 years’ experience with clear evidence of building and leading successful teams
Bachelor’s degree (or equivalent qualifications and experience) in a relevant scientific or engineering discipline
Advanced knowledge of gmp/glp requirements related to pharmaceutical, medical device and antimicrobial testing services
Membership of relevant industry organizations (i.eSociety of quality assurance, american society for quality)
#li-al1 company overview: element is one of the fastest growing testing, inspection and certification businesses in the worldGlobally we have more than 6,500 brilliant minds operating from 200 sites across 30 countriesTogether we share an ambitious purpose to ‘make tomorrow safer than today’.
When failure in use is not an option, we help customers make certain that their products, materials, processes and services are safe, compliant and fit for purposeFrom early r&d, through complex regulatory approvals and into production, our global laboratory network of scientists, engineers, and technologists support customers to achieve assurance over product quality, sustainable outcomes, and market access.
While we are proud of our global reach, working at element feels like being part of a smaller companyWe empower you to take charge of your career, and reward excellence and integrity with growth and development.
Industries across the world depend on our care, attention to detail and the absolute accuracy of our workThe role we have to play in creating a safer world is much bigger than our organizationDiversity statement: at element, we always take pride in putting our people firstWe are an equal opportunity employer that recognizes diversity and inclusion as fundamental to our vision of becoming “the world’s most trusted testing partner”.
All suitably qualified candidates will receive consideration for employment on the basis of objective work related criteria and without regard for the following: race, colour, age, religion, gender, national origin, disability, and/or protected veteran status, or other characteristics in accordance with the applicable governing lawsTic council statement: element is proud to be a full member of the testing, inspection & certification council (the “tic council”), an international association representing independent testing, inspection and certification companies.
Members of the tic council must implement and abide by the tic council compliance codeElement has therefore issued an overarching code of conduct which is supported by our compliance programmeA copy of the code of conduct and more information about our compliance programme can be found in the governance and integrity section of www.element.com.
