Quality Assurance Officer - Derby, Derbyshire, United Kingdom - Bionical Emas

Description

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 fora QA Officer to beresponsible 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

PLEASE NOTE : We will be longlisting applications as soon as we receive them, so please apply early to register your interest.

We Are Bionical Emas

We are proud of our people and proud of our achievements. We encourage and hire people with diverse backgrounds, voices, beliefs, and perspectives into our growing global workforce. We do not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, and pregnancy-related conditions), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state or local laws and ordinances. Bionical Emas' management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment.

Bionical Emas offers equal opportunities and is committed to diversity in its workplace and providing accessibility accommodations to applicants with physical and/or mental disabilities. If you are interested in applying for employment with Bionical Emas and need accommodation or special assistance, please let us know by sending an email with your request to the recruitment team at .

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.

Protecting your privacy and the security of your data is a longstanding top priority for us. Please consult our Privacy Notice to know more about how we collect, use, and transfer the personal data of our candidates. Our Privacy Notice explains what personal information we may process, where we may process your personal information, our purposes for processing your personal information, and the rights you can exercise over Bionical Emas' use of your personal information. By applying for the above position, you confirm that you have reviewed and agreed to our Data Privacy Notice for Candidates: Privacy Policy - Bionical Emas applicable to your place of residence.

Powering the patient journey