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Qos Compliance Associate
3 months ago
Our purpose defines why we exist:
to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose.
Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a privilege.
Research & Development:
In R&D, we're full of highly skilled talents that include Scientists, Engineers, Medical, Clinical and Regulatory professionals - all working to create a cleaner, healthier world.
With nine Centres of Excellence, we continually seek out new opportunities by using science, our entrepreneurial flare and our fearless innovation to develop and enhance our existing portfolio, never compromising on quality or performance.
We do the right thing, always, by ensuring we act with responsibility and integrity, by complying with regulatory legislation across the globe, whilst ensuring our products are safe for our consumers and are to the highest quality.
The size of our organisation means you'll have the opportunity to learn and work in different functions within R&D, giving you exposure to different disciplines, teams and environments.
You will also have access to our R&D Academy, designed to develop our team and allow you to grow in our great organisation.
About the role:
QOS & Compliance Associate
Location - Kingston Upon Hull
Competitive Salary and Excellent BenefitsYour responsibilities**:
Key QOS Author responsibilities:
- Authoring of the Quality Overall Summary (module 2.3 of the CTD)
- Performing a final review of the full Module 3 prior to submission
- Provide feedback to teams and predict potential regulatory authority questions
- Act as a consultant for R&D teams at any stage of product development
- Provide training and maintain templates and checklists to enable Module 3 authors to produce high quality Module 3 documents
Key Compliance Officer responsibilities:
- Monitor and input into open deviations, change controls, and risk management records and work with the Stability and Scientific Services teams to ensure they are completed to the right standard and don't go overdue
- Track and input into scheduled tasks (e.g selfinspections, data integrity governance plans, equipment maintenance, SOP updates) and work with the Stability and Scientific Services teams to ensure they are completed on time and to the required standard
- Prepare and present KPIs as needed, for example in the Stability and Scientific Services team meeting and the HTSG managers meeting
The experience we're looking for:
- Qualified to degree standard in a relevant scientific discipline
- Experience in a product development environment (formulation and/or analytical).
- Experience working with a document management system (ideally with direct experience of CARA) as well as Microsoft Office suite.
- Experience working with module 3 documents, including authoring, reviewing and approving
- Able to prioritise multiple work streams and work to deadlines
The skills for success:
R&D, Product Lifecycle Management, Business Partnership, Collaboration, Partnership building, Collaborator, Propose improvement, Accountability, Adaptability, Quality One, Computer skills, QOS, Regulatory, Dossier Authoring and Reviewing
What we offer:
With inclusion at the heart of everything we do, working alongside our four global Employee Resource Groups, we support our people at every step of their career journey, helping them to succeed in their own individual way.
We invest in the wellbeing of our people through parental benefits, an Employee Assistance Program to promote mental health, and life insurance for all employees globally.
Equality:
We recognise that in real life, great people don't always 'tick all the boxes'. That's why we hire for potential as well as experience.
Even if you don't meet every point on the job description, if this role and our company feels like a good fit for you, we still want to hear from you.
All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion, faith; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law.
