We are seeking to appoint a Senior QA Auditor to join our team and make a positive impact in a growing and progressive CRO.
This is a fantastic opportunity to join an experienced and friendly QA department.
The focus of the job is primarily to manage vendor audits/qualifications to match customer expectations, with the support of the rest of the QA team and Subject Matter Experts.
This is an exciting area requiring a wide range of interpersonal skills, creativity and analytical thinking, since vendors provide a very wide range of services.
You will also be involved in the management of study/system audits, quality issues arising and the general QMS over all MAC's operations, as required.
You will be largely working from home, with periodic visits to predominately UK sites (Glasgow, West Yorkshire, South Yorkshire, Teesside, Manchester, Merseyside, Lancashire and South Staffordshire), with opportunities for international travel as the company grows.
KEY SKILLS, KNOWLEDGE AND QUALIFICATIONS REQUIRED: Some experience of QA within the Pharmaceutical business Excellent verbal and written communication skills Good attention to detail and organisational ability A logical approach to problem analysis and solutions Excellent initiative to be able to work alone and with a team Good skills with MS Office A friendly and helpful disposition Ability to communicate and negotiate with internal stakeholders effectively The ability to write clear and concise reports Ability to understand a CRO and/or SMO QMS Ability, after training, to grade audit/report findings appropriately and manage their workflow A degree in a science-related subject Ability, after training, to conduct vendor qualifications based on risk Ability, after training, to perform and train others in QA audits and activities within the CRO business.
RESPONSIBILITIES: Primarily, performing vendor qualifications Performing study, system, and other types of audits as required.
Management of QA documentation and follow-up of findings Liaising with vendors, SMEs, colleagues, Sponsors and Vendor Management department as necessary, to ensure efficiency and customer satisfaction Keeping updated with the latest regulations and guidelines relevant to the role Management of quality issues arising, as required Assisting in the management of any applicable risk assessments Assisting the rest of the QA team in study/system/vendor audits, or any other QA responsibilities, as required Hosting or assisting with external sponsor/regulator audits as required Compliance with MAC health and Safety policy Compliance with MAC policy on equality and diversity To maintain any professional qualifications required for the role, including continuous personal development.
To work according to MAC SOPs, guidelines and policies To work according to current data protection standards and practice good information management.
Maintenance of strict confidentiality of patient and business-related data.
To maintain a high level of initiative and personal responsibility, liaising appropriately with team members and managers to ensure the job role is efficiently carried out To support the aims of MAC and to represent MAC appropriately in a professional way to all our customers PHYSICAL, WORK ENVIRONMENT, TRAVEL DEMANDS: Periodic UK travel to investigator sites and meetings, with opportunity to travel to international sites as the business grows.
Must be confident driver with full license.
This role is home based and therefore we require you to have a set up at home that allows you to work comfortably.
This includes an appropriate desk and chair (excl.
IT equipment which we will provide), please confirm you are able to do this before proceeding with your application.
BENEFITS: Competitive salary in keeping with pharmaceutical industry standards that will reflect experience Health Insurance Free onsite parking 25 days annual leave (increasing in increments to 30 days after 6 years' service) Your birthday off work MAC is a full-service global Contract Research Organisation (CRO).
We also own a network of research sites.
Our mission is to serve with honesty and integrity to make an outstanding contribution to human health.
We invite applications from highly motivated candidates, with a desire to fulfil their full potential.
You will be working with an organisation that sees you as an investment and is keen for you to achieve your career aspirations.
Please email ****** should you require any special arrangements or reasonable adjustments to be made throughout this selection process.
This will enable us to accommodate your request as necessary.