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External Affairs Assistant
Research Scientist- Assay Development
Quality & Regulatory Manager
Reference No: EAA17
The British In Vitro Diagnostics Association (BIVDA) is the national industry association for manufacturers and distributors of in vitro diagnostic tests. The role of BIVDA is to support the activities in the UK of its members and to campaign for a wider understanding of the value of diagnostic testing in healthcare. The office works routinely with politicians, NGOs and the media as part of its external activity. You can read more about who we are here www.bivda.co.uk
We are looking for a skilled and motivated individual to join us as External Affairs Assistant. You will work closely with the External Affairs Manager and the Chief Executive to support the goals of BIVDA. We have a bright, modern office in a convenient location and you would be an important part of a small, friendly team.
- Support the External Affairs Manager and Chief Executive across public affairs, policy and communications
- Support the effective running of Member Working Parties, including the External Affairs Working Party
- Building strong relationships with the BIVDA membership and stakeholders
- Contribute to the website and social media campaigns
- Assisting with stakeholder mapping and maintaining a database of stakeholder engagement
- Contributing to BIVDA’s publications including the weekly members’ newsletter and stakeholder newsletter
- Lead on parliamentary and media monitoring
- Arranging meetings, drafting letters and general support to the Chief Executive as required
- General administrative support and other duties as required
- Educated to degree level, with a minimum 2:1 grade
- Excellent written and oral communication skills
- Demonstrable interest in healthcare policy landscape
- Good interpersonal skills, able to work well with colleagues, members and stakeholders
- Positive and helpful attitude to work
- Attention to detail
- Good IT skills
- Willingness to work flexibly when required
Location: BIVDA Headquarters, 299 Oxford Street (5th Floor), London, W1C 2DZ
To apply, please submit your CV and covering letter to firstname.lastname@example.org quoting the reference Application EAA17 in the subject line.
Closing date 11th August 2017
QuantuMDx Group is one of the most exciting life sciences, tools and diagnostics companies to emerge from the UK in recent years. Due for commercialisation in 2018, their signature device, Q-POC™, is a low-cost, simple-to-use, portable diagnostic device for 10 – 20 minute diagnosis at the patient’s side. The robust device will identify the presence and strain of an infection, ensuring the right drug is prescribed first time, facilitating a more intelligent use of antibiotics. Further to this, globally distributed Q-POC™ devices will geotag and anonymise pathogen data, sending it to the cloud for real-time disease and drug resistance monitoring, and rapid detection and containment of pathogens.
Q-POC™ is ideally suited to help address the humanitarian health burden by offering goldstandard molecular diagnostics at a fraction of the price of traditional testing. Once the device has passed regulatory approval it will be available for highly multiplexed diagnostic and drug susceptibility testing for just a few dollars, in any setting globally.
This role requires an Assay Research Scientist to support the QuantuMDx Group commercialisation programme by working within the Assay team to develop the Company’s diagnostic platform, the Q-POC™.
Please send a CV and covering letter to Amy Edwards email@example.com Tel: 0870 803 1234
Closing date: 31/8/17
ERBA Molecular is an innovative molecular diagnostics company applying its commercially validated proprietary technology in sample preparation, amplification and detection to produce novel workflow based solutions to reduce the complexity of molecular testing.
We are currently recruiting for a Quality & Regulatory Manager to join our team in Ely on a full-time basis. The QA/RA Manager will be responsible for documenting and maintaining a Quality Management System and maintaining its effectiveness in accordance with the requirements of relevant international standard(s) on behalf of the company and its affiliates as well as providing regulatory input into the Product Development process and CE marking submissions.
- Achieve and maintain ISO13485 certification for the organisation.
- Maintain a quality management system which includes:
- documented statements of a quality policy and objectives;
- a quality manual;
- documented procedures and records required by international standard ISO 13485;
- documents needed by the organisation to ensure effective planning, operation and control of its processes;
- any other documentation specified by national or regional regulations;
- a robust and compliant CAPA, complaint, NCR, internal audit process; and
- supplier management processes.
- Identify the processes needed for the quality management system, their interactions, and their application throughout the organisation.
- Determine criteria and methods needed to ensure that both the operation and control of these processes are effective.
- Ensure the availability of information necessary to support the operation and monitoring of these processes.
- Lead the business in problem resolution and root cause analysis methodology in order to identify corrective and preventive actions and minimise the risk of (re)occurrence. Support operators in investigations and provide guidance where required on non-conformances and planned deviations.
- Support the development of LEAN methodology while driving improvements across the business.
- Build effective relationships with all Erba Molecular staff, creating a culture of Quality by Design and open communication between the Quality department and other departments.
- Measure operators’ engagement with the Quality System on a regular basis and obtain feedback on areas to improve, while remaining compliant at all times. Design and carry out own activities to promote Quality within the organisation.
- Develop effective relationships with other external and internal partners; including but not limited to the company’s Product Development Process and Group, manufacturing partners; licensees; and other members of the ERBA Group to ensure quality and regulatory compliance for the business, ensuring ownership of quality as an ongoing and proactive activity.
- Support the Product Development Group and provide input in the Product Development Process where required from a Quality and Regulatory perspective and in the creation of technical files.
- Support other members of the Operations group from a Quality aspect, including supplier management, product transfer and lab management.
- Manage the day to day aspect of document control and issuance of training records related to QA, manage the training matrix reflecting and identify gaps in training per operator role. Work with team leaders to advise on required training and deliver training on quality SOPs.
- Conduct spot checks and internal quality audits regularly and in a supportive constructive manner, coordinate a review of the results and ensure corrective actions are agreed and implemented in the timescales set.
- Drive quality and business improvement opportunities to deliver customer fulfilment, reduced waste and higher profitability.
- Act as deputy to the QA and Operations Director in Quality and Regulatory matters
- Promote a positive health and safety culture in the workplace by following the training received and complying with all health and safety procedures.
The successful candidate will have:
- Quality management experience:
- Quality experience within the medical device/pharmaceutical industry
- At least 3 years’ experience within an ISO 13485 environment
- Knowledge of the Medical Device Directive 93/42/EEC and experience creating and maintaining CE technical file
- Experience of promoting Continuous Improvement
- Lead Auditor trained
- Degree level education or equivalent experience with either a Scientific, Management, Quality or Engineering background is desirable
- Experience of CE Marking Submission applications for US and Asian markets desirable
- Experience of FDA, MHRA, MDD desirable
- Knowledge of new MDR directive desirable
- Experience in presenting effectively at team/company meetings and, when appropriate, outside audiences
- Confidence in training others and ensures own expertise is disseminated as widely as necessary
- Ability to communicate at all levels and bring a culture of employee engagement to the QMS through own positive supportive communications to employees
- Ability to suggest improvements/solutions to practical problems or procedures
- Responds to the needs of team members and provides help in areas of own expertise
- Ability to work independently and be a self-starter
- Microsoft Sharepoint 2010 knowledge desirable
Please submit your CV and covering letter quoting reference QA-BV to firstname.lastname@example.org
Closing date for applications is Friday 11th August 2017.
Thank you for taking an interest in the career opportunities at ERBA Molecular; we are a successful and dynamic company that is always looking to add the right candidate to our team.
Direct applicants only – no agencies please.
Recruitment – Data Privacy Notice:
Your personal information will be held securely in Erba Molecular’s systems so that we can look after your potential employment relationship with the company.
Personal information may include, but is not limited to, your application; curriculum vitae; emails; letters; evidence of entitlement to work in the UK; references; and any additional information provided by you or others in support of your application.
We will not retain your personal information for longer than is necessary for processing your application, or for legal or regulatory requirements.