Reference Material Support, Open to flexible working
‘Be You’ at GSK
At GSK, we're a company with a purpose to help people do more, feel better and live longer. We realise that our purpose starts with us. When we feel at our best, we perform at our best. Therefore, we want all applicants to be able to perform their best throughout the recruitment process.
We will be delighted to hear from talented individuals that align to our values. These are at the heart of everything we do and include: Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.
When you set out on your adventure at GSK, we make a deal. You commit to living our values and expectations and performing against our Innovation, Performance and Trust priorities. In return, GSK commits to providing the right environment for you to thrive. Together, we build an environment where we can all thrive and focus on what matters most to each of us.
Reference Material Support (Fixed Term Contract)
In this role you will…
- Utilise internal company systems to identify regulatory documents for Active Pharmaceutical Ingredients (APIs) registered in Japan.
- Identify specific registered details relating to reference materials (APIs & related impurities) and perform a gap analysis against current analytical data and ways of working.
- Document gap analysis and provide recommendations on any remedial work to be completed.
- Prepare project plans, and provide regular updates to the project team.
- Prepare analytical knowledge transfer documents to close gaps in analytical testing.
- Prepare reports to summarise gaps identified, remedial work conducted and any further actions to be taken for materials that fail to meet the registered specification.
- Create specification documents to ensure future batches of reference material are sourced / synthesised to meet registered details.
The Reference Materials Group are responsible for management of the sourcing, analysis, certification and supply of reference materials used in the analysis of API & finished product throughout the GSK network. This small team, based at the Barnard Castle Site, works with an external service provider to deliver Reference Materials to the business.
Qualifications & Skills:
- Bachelor of Science (Chemistry) or related scientific discipline.
- Good working knowledge of analysis & certification of Reference Materials.
- Experience in working with registration documents. Good knowledge of Global GMP and regulatory requirements.
- Experience of electronic document management and archival systems.
- Knowledge of test methods used for the analysis of pharmaceutical raw materials, APIs and products.
- Ability to work independently and meet targets.
Preferred Qualifications & Skills:
- M.Sc. or Ph.D.
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.