Job Title: Quality Assurance Auditor
Job Category: Quality
Job Location: Manchester, United Kingdom
This is an exciting opportunity for a Quality Assurance Auditor to join our dynamic team based in Manchester.
Intertek’s support for Chemical & Pharmaceutical industries goes beyond assurance, testing, inspection, and certification. Their global network of sophisticated, highly regulated and advanced laboratories, coupled with their scientific expertise offers clients a broad scope of expert support, from accelerating new product research and development to helping them protect their intellectual property.
This resource, coupled with field of regulatory experts and experienced scientists and engineers from the industry, enables Intertek to ensure the safety, quality and performance of new products, while providing true problem-solving and business improvement support.
Intertek Pharma Services Manchester (IPSM) has an extensive range of analytical instrumentation and provides analytical services to customers in the pharmaceutical, biopharmaceutical, personal care and speciality chemical sectors in a GLP, GCP and GMP regulated laboratory.
This role will perform audits/ checks for GLP, GMP, GCP and non-GxP data as necessary to assure data integrity.
Further responsibilities will be to:
•perform GLP, GMP, GCP and related quality system audits necessary to assure compliance with all relevant current National and International Quality Standards and customer requirements
•assist the Quality Assurance Senior Team Leader in the overall implementation of the Quality function
•check/ audit analytical technical data, associated records, facility and operational systems, to monitor and assure management of data integrity/ compliance with all relevant regulatory requirements
•provide general support to all Quality Unit activities relating to GLP, GMP, GCP, and other similar Quality Systems established in order to ensure that the appropriate standards and effective working systems and relationships are maintained and where necessary improved
•schedule and inspect GLP study procedures and related facilities to ensure compliance with regulatory requirements and identify and report any areas of non-compliance to both study and facility Management
•audit and/or Review GMP validation reports, C of As, test certificates, data for batch release etc to ensure that they are internally consistent, accurately and completely reflect the raw data and meet current Good Manufacturing Practice standards and regulations
•audit and/or Review GCP reports, C of As, test certificates, data for analysis of samples from clinical trials etc. to ensure that they are internally consistent, accurately and completely reflect the raw data and meet current Good Clinical Practice standards and regulations
•identify and contribute to areas for improvement within the quality management systems to ensure compliant and efficient systems
•assist in monitoring of the Automated Systems Qualification program, providing advice and guidance where necessary
The Manchester site operates on a flexible working basis where core hours are 37.5 hours per week. The role holder must be willing to work to a flexible schedule as the business requires.
Required skills and experience
•Good IT literacy skills (Word, Excel, PowerPoint, SharePoint)
•Ideally degree qualified in BioChemistry or Chemistry (or related scientific discipline)
•A sound working knowledge of GLP, GMP, GCP and other analytical related quality standards
•Proven industry experience of performing detailed audits for data integrity within the above regulatory framework
•Industry experience in analytical science (chromatographic methods e.g. HPLC, GC, LC etc. and/ or other pharmaceutical characterisation techniques)
•Promotes company values to others and supports values in daily activities and decisions
•Results driven to focus contribution on activities which meet company goals and deliver the greatest value
•Ability to critique and improve activities through continuous improvement and innovation
•Ability to demonstrate exceptional customer service
•The ability to demonstrate respect, equity and empathy for a diverse community
•Encourage teamwork (promote operational synergies and alignment) to support each other, our customers and grow together
•Highly energised mind-set with willingness and desire to learn and adapt individually
•Drive performance by ensuring performance expectations are met
•Fosters integrity and honesty
•Ensure compliance to company, industry and regulatory standards
•Highly organised with strong attention to detail
•Confident communicator(written/ oral) and able to build rapport, quickly and effectively
•Demonstrates flexibility and resilience in order to meet the demands of the role
•Able to act on own initiative
•Excellent time management
Please provide a CV, Covering Letter (outlining your suitability for the role) and Salary Expectations to email@example.com including the reference Intertek352. All candidates will be required to confirm eligibility to work in the UK before starting employment.
As a matter of courtesy, we will try to respond to all applications. However, due to the volume of applications received, we may not be able to respond to individual candidates. If you have not been contacted within 4 weeks unfortunately, your application has been unsuccessful. Please do not let this deter you from applying for vacancies in the future should you meet the minimum requirements of the role.
Intertek operates a preferred supplier arrangement and we do not accept unsolicited approaches from agencies
4th December 2017