Quality Assurance Administrator

3 months ago

Derby, United Kingdom Bionical Emas Full time

**A Career with Purpose**

Bionical Emas is a global Clinical Research Organization (CRO) bringing life-changing medicines to patients around the world. We combine Clinical Development, Clinical Trial Supply (CTS) and Early Access Programs (EAP) to deliver a unique, seamless service to our pharma and biotech clients.

At Bionical Emas, you will have the chance to develop your career while working with an outstanding team of people. Our shared values create a unique culture that guides our actions and defines who we are. You will be a part of a welcoming, flexible, and supportive culture that values trust and belonging. We believe that creating opportunities for our people to develop their skills is crucial to our growth and success. If you are inspired by changing the lives of patients all over the world, we’d love to hear from you.

**About the Role**

We are looking for an admin assistant to be responsible for assisting in the provision of the company’s quality assurance functions, including the company’s Quality Management System (QMS). Ensuring compliance with Good Distribution Practice (GDP), Good Manufacturing Practice (GMP) & driving continuous improvement to ensure compliance with all relevant regulatory, best practice & company requirements.

**What will your job look like?**
- Responsible for assisting the Quality Assurance Manager and Quality Assurance Team with building, maintaining & constantly developing the QMS
- Ensuring that at all times the QMS is compliant with the Company’s MHRA Process Licences, GDP, GMP and equivalent regulations/ codes of practice
- Logging corrective/preventative action (CAPA) plans arising from self-inspections, client/customer audits, competent authority inspections, complaints & deviations
- Tracking & closing actions from CAPA plans within an appropriate timeframe
- Logging, tracking, and investigating quality events (deviations and complaints), including documenting CAPAs where required
- Performing necessary steps to ensure customers are adequately qualified to receive medicinal products
- Responsible for the collation of all required documentation to approve CTS transactions
- Assist with the necessary steps to ensure suppliers are adequately qualified, including verification of supplier licences
- Ensuring accuracy, quality & accessibility of quality records, including but not limited to training records
- Assisting with training on approved SOPs & controlled documents as required
- Understanding & complying with all of the business’s systems, processes and standards

**What will you need to succeed?**
- GCSE or higher educational standard
- Credible & confident communicator both written and verbal
- Commercially astute & highly customer focused
- Strong analytical & problem-solving ability with a hands-on approach and a ‘can do’ attitude
- Strong organisational skills with good time management skills
- Good attention to detail & ability to work accurately in a busy and dynamic environment

**What will you get in return?**

We want you to do your best work We care about our people’s well-being, their personal development and providing a true work-life balance. Our benefits are aligned with our culture and values and are intended to maximize your experience working for us. Here are some of the benefits you can expect from working for Bionical Emas.
- 25 days of vacation
- Vacation days purchasing scheme
- 1 extra vacation day per each 3 years of service
- Discretionary Annual Bonus
- Sabbatical of 3 to 6 months (after 2 years of service)
- 1 volunteer day per year
- Free food and beverages at all offices
- Life Insurance
- Health Insurance and Employee Assistance Programme
- Employee Support Networks - help us continue to build on our inclusive culture
- Flexible and hybrid work
- Training and Personal Development Program

**Does this sound like you?**
- It is time to apply, and we can’t wait to hear from you_

Even if you don't meet 100% of the requirements, be confident in yourself and don't hesitate to apply

**We Are Bionical Emas**

**We Are Bionical Emas,** where each person is unique. We celebrate individuality while encouraging our talents to work as a team. Together, we make a difference by powering an inclusive future for all. Be you, with us.

**Powering the patient journey

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