Our client is looking for a QA Officer to join their team in the West Midlands! Responsibilities include;
* Transfer from MDD to MDR
* Maintenance and continuous improvement of the Quality Management System for Medical Devices. Including updating and writing SOPs, risk management files, post market surveillance documents, and clinical evaluation reports.
* Efficient administration and management of Regulatory Technical Files.
* Raising CAPA's, Change Controls, Non- conformances, Supplier Corrective Actions (SCARs) and providing resolution where applicable to support maintenance of certification/ standards.
* Involved in raising, documenting and investigating product complaints.
* Review and approve PQRs (Product Quality Reviews reports)
* Liaise with subcontract manufacturers/ suppliers regarding quality/ regulatory issues.
* To ensure compliance to applicable medical device regulations and standards, including the MDR requirements. (Ensure the company's products meet the regulations of the MHRA)
* Writing clear, accessible product labels and patient information leaflets.
* Specifying storage, labelling and packaging requirements.
* Preparation and participating /hosting of audits by certification bodies/ regulatory agencies.
* Advise the Regulatory Manager of any regulatory/ quality gaps/ issues within the organisation.
* Complying to GDP- Ensuring that outsourced activities are correctly defined, agreed and controlled.
* Assist in solving any issues, queries, or problems within the department and across other business functions.
* Undertake other related responsibilities commensurate with the evolving objectives of the post as may reasonably be expected.
* Degree in Life Sciences
* Significant and demonstrable experience of working in a similar Quality Assurance related role within the Pharmaceutical Industry
* Excellent working knowledge of ISO 13485: 2016, MDD and MDR 2017/745
* Excellent oral and written communication skills and ability to present at different levels of the organisation
* Strong interpersonal skills with the ability to work cross functionally across the business, with suppliers and customers
* A proven track record to meeting highly challenging targets/ deadlines
* Ensures high quality and accurate work with high attention to detail
* Self-motivated and proactive with the ability to work under minimal guidance / supervision
* Decisive thinker, ability to multi-task, remain calm under pressure
* Strong work ethic and high levels of resilience
* Good numerical and analytical skills
* Full driving licence is desirable
What should you do next?
This QA Officer role is one not to be missed; it encompasses the opportunity to join a reputable pharmaceutical company! To discuss further, please submit your current CV.
Unless otherwise stated, if applying for a job within the European Union, you must ensure that you are already authorised to work there.
Carrot Pharma Recruitment Ltd acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role.