Auditor (Supplier Quality), Open to flexible working
We now have 2 exciting opportunities available to be part of the Central Supplier Quality Audit and Compliance (SQ A&C) function supporting the Pharma Supply Chain. We are looking to recruit 2 Supplier Quality Auditors. The SQ A&C Pharma 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.
The Supplier Quality Auditor reports directly to the Supplier Quality Audit Operations Manager. The purpose of the 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, the successful candidate 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, the successful candidate will maintain audit and user site-data in the appropriate GSK supplier management systems and complete Supply Chain Risk Assessments for suppliers as assigned. 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 (included);
- Performing GMP/Quality System assessments/audits of assigned suppliers; making risk-based recommendation 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).
- Completion of assigned Supply Chain Risk Assessments for applicable suppliers to support release decisions by GSK site "QPs" (Qualified Persons).
- Supporting change controls from assigned suppliers (as needed) as per current procedures.
- Supporting 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 assigned).
TRAVEL: Please Note that there is a high proportion of travel involved with this role (throughout Europe, particularly in Italy and Germany where there are number of key suppliers). It is anticipated that this will represent circa 30% to 50% of the role.
LOCATION: The successful candidates will be based at one of the following GSK sites: GSK House, Ware or Barnard Castle (UK), Evreux or Mayenne (France), Parma (Italy) Poznan (Poland), or Munich (Germany).
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 whilst 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 organise and prioritise 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.
Applicants are asked to draw attention in their application to how they meet the above criteria in order to be successful for interview selection.
CLOSING DATE for applications: Monday 8th of March 2021 (COB).
When 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.
GSK is a science-led global healthcare company that researches and develops a broad range of innovative medicines and brands. Our products are used by millions of people around the world, helping them to do more, feel better and live longer. Employing over 100,000 people globally, we have 71 manufacturing sites around the world.
- Relevant experience (ideally gained from the 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.
- Knowledge of / experience in API, sterile, parenteral, and/or biopharmaceutical manufacturing processes / environments
- Auditor certification from relevant external organization and/or GSK auditor certification.
As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.
Important notice to Employment businesses/ Agencies
GSK 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.