Quality Assurance Officer

6 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 a QA Officer to be responsible for supporting the implementation and the maintenance of the company’s Quality Management System supporting the operational functions of Clinical Trials Supply (CTS) and Early Access Programs (EAP). Ensuring that all activities undertaken are authorised by the WDA and MS licence and complies with the GDP and GMP guidelines.

Supporting and engaging with core business functions, ensuring processes are effective and efficient, identifying any continuous improvement opportunities. Ensuring all actions undertaken are performed within the defined timescales and escalate any breaches of GDP/ GMP to senior QA Management.

**What will your job look like?**
- Support in the implementation and maintenance of the QMS. This includes, but not limited to, management of deviations, CAPA, change control, SOP reviews
- Perform assigned duties as per all relevant SOP’s, ensuring that training has been completed prior to commencement of any task
- Will ensure that all QMS quality records (i.e Deviations, CAPA, risk assessment etc.) are managed through to completion, ensuring that records are completed within their due date
- Supporting in the creation, review & approval of applicable quality statements (i.e Pedigree Statement) and declarations, as required
- Support in the creation, review, & approval of SOPs & controlled documents as required
- Provide training and support across functional groups within the business, as directed by Senior QA management
- Will support in the execution of the internal audit/self-inspection schedule, as required
- Provides support in the compilation of QA reports & presentations, such as the Quality Management Review and QA KPI’s, as directed by Senior Quality Management
- Reviewing notifications from Competent Authorities and MAH’s, such as recall notifications and reviewal of the suspended and revoked licence reports. Will escalate to Senior Quality Management upon identification of any notification that impacts Bionical product and/ or licences
- Perform qualification activities of medicinal product suppliers, GMDP vendors and customers, HCPs and Ship to addresses, as per procedure
- Undertake all activities as part of the role with accountability, professionalism & integrity
- Responsible for managing own professional development

**What will you need to succeed?**
- An understanding of the pharmaceutical industry
- Credible & confident communicator (written and verbal) at all levels
- Hands-on approach, with a ‘can do’ attitude
- Previous QA experience is essential
- A-Level or higher education is essential

**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)
- 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

**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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