Supplier Quality Auditor

Job title:

Supplier Quality Auditor

Company:

GlaxoSmithKline

Job description

Supplier Quality AuditorJob purpose:We now have an exciting opportunity available to be part of the Central Supplier Quality Audit and Compliance (SQ A&C) function supporting the Global Supply Chain. The SQ A&C team supports the wider GSK manufacturing network globally by promoting quality and compliance throughout the product life-cycle. This is accomplished through quality assurance activities supporting the GSK supply chain, specifically GMP assessment of quality critical materials and services utilized throughout the GSK manufacturing network.As the Supplier Quality Auditor, you will directly report to the Supplier Quality Audit and Compliance Head. The purpose of your role is to significantly contribute to the assurance that material and service suppliers to GSK’s manufacturing and supply-chain sites are in adequate compliance with GSK requirements and all applicable standards for relevant Regulatory Authorities.Day-to-day, you will be generally focused on planning, executing and documenting GMP and Quality Systems compliance audits/assessments for a number of assigned suppliers in region and managing associated supplier action plans arising from those audits/assessments to close identified gaps.In delivery of the above, you will maintain audit and user site-data in the appropriate GSK supplier management systems. You will also have the opportunity to provide expertise and support for supplier Quality Assurance Agreement negotiations and supplier change controls (as required/applicable).Key Responsibilities:Performing GMP/Quality System assessments/audits of assigned suppliers; making risk-based recommendations on supplier GMP approval status (including proposals for continued use of suppliers with marginal compliance) and documenting assessments/audits in relevant systems.Agreeing appropriate corrective and preventive action (CAPA) plans with suppliers and follow-up on the completion of CAPAs (within agreed timelines).Effective communication of assessment outcomes to internal and external stakeholders.Ensuring audit-related documentation is effectively communicated and that CAPA-related documents are reviewed and responded to within targeted timelines.Maintenance of “auditee” (supplier) profiles in data systems, ensuring that supplier data associated with the supplier assessment and user sites are kept up-to-date (based on currently available information).Supporting change controls from assigned suppliers (as needed) as per current procedures.Supporting if needed negotiation of Quality Assurance Agreements (QAAs) with assigned suppliers.Collating identified risks and escalating high risk issues/situations to ensure management and stakeholders understand technical, regulatory and quality risks (and that appropriate mitigating actions are identified).Provide support to GSK sites undergoing regulatory/customer inspections as it relates to SQAC supplier quality activities (as assigned).TRAVEL: Please note that there is a high proportion of travel involved with this role (throughout Europe). It is anticipated that this will represent 30% to 50% of the role.LOCATION: The successful candidate may be based at any of the GSK manufacturing sites in Europe/UK. Location at the following GSK sites is preferred: Evreux (France), Marburg (Germany), Dresden (Germany), Wavre (Belgium). Please Note the amount of travel required.About You:As this role is multi-faceted and includes liaising with a wide variety of on-site and third-party production and operations teams, you will be a confident, self-motivated and self-managing individual who has strong auditing experience (obtained while working in quality and/or manufacturing at a complex manufacturing site) across a wide variety of commodities and proven ability to work remotely as part of a matrix organization. You will be passionate about quality-control and auditing, with strong people skills and a continuous improvement mindset. Effective written and verbal communication and excellent interpersonal skills, as well as the ability to organize and prioritize workload are considered essential skills as well as ability to speak and write technical documents in English. You will be curious and able to assimilate multiple information sources into rational conclusions. Experience in / knowledge of API manufacturing, sterile manufacturing or biopharmaceutical manufacturing a definite plus.

Basic Qualifications:Relevant experience (ideally gained from working in a highly regulated environment like Pharmaceutical Manufacturing).Degree in Life Science or other relevant discipline.Knowledge of current GMP requirements within major pharmaceutical markets.Knowledge and application of the principles of the Quality Management Systems (QMS).Comfortable with verbal and written English.Preferred Qualifications:Knowledge of / experience in API, sterile, parenteral, and/or biopharmaceutical manufacturing processes / environmentsAuditor certification from relevant external organization and/or GSK auditor certification.CLOSING DATE for applications: Friday 9th August 2024When applying for this role, please use your CV to describe how you meet the competencies for this role (as outlined in the candidate expectations above and qualifications below). The information that you have provided will be used to assess your application.If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.Why GSK?Uniting science, technology and talent to get ahead of disease together.GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK’s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Expected salary

Location

Wavre, Brabant Wallon

Job date

Sat, 13 Jul 2024 01:56:46 GMT

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