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Head of RAQA Pharma
Location | Worthing |
Discipline: | Regulatory Affairs |
Job type: | Permanent Full Time |
Job ref: | 006688 |
Published: | 3 months ago |
We are looking for a Head for our Pharmaceutical QARA team. You will be an ambitious and experienced leader in pharmaceutical quality and regulatory matters. You will be a strategic thinker, aware of the impact that an excellent and efficient QARA team bring to the achievement of Rayner's strategic goals.
You will be responsible for meeting agreed budget and project targets and building and maintaining positive relationships with internal and external stakeholders.
What You'll Be Doing
- Developing strategy with top management
- Setting and reporting on team objectives
- Working with global leadership to ensure the success of commercial plans
- Ensuring that Rayner's existing portfolio of ophthalmic medicines remain available to UK and US customers
- Ensuring that Rayner's plans for expansion into other global markets are managed and achieved In a timely and efficient manner
- Managing the Pharma QARA team, Maintaining and delivering
- Continual Improvement of the Rayner Pharma QMS
- Running a programme of Internal and Supplier Audits to ensure compliance to all applicable regulations in target markets
- Hosting External Regulatory Body audits of the Pharmaceutical QARA systems
- Monitoring and reporting on KPIs relevant to the department
- Managing relationships with key external stakeholders (e.g. contract manufacturers, logistics contractors, pre-wholesalers, test houses, etc.)
What Experience Do You Need
- Registered with MHRA as a Responsible Person for WDA(H)
- Life Science degree or equivalent professional qualification
- Thorough understanding of the manufacture, testing and quality assurance of sterile products
- Direct experience in a similar role, covering the creation, maintenance and submission of pharmaceutical registration documents for UK, EU, or USA
- Experience in some area of ophthalmology
- Experience as a Quality System leader in the pharmaceutical industry
- Demonstrable knowledge of the regulatory environment relating to the manufacture of sterile
- Experience of sterile pharmaceutical products
What We Can Offer You
- Private healthcare
- Wellbeing allowance up to £300.00 a year
- Monthly yoga sessions and quarterly massages
- Annual programme of fun events
- On site restaurant
- Enhanced maternity & paternity leave
- On site parking
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