The Quality and Compliance Associate will assist the Quality Manager in implementation of ESMS QA strategy in order to ensure that Quality requirements are met at all times and that the Quality System meets the needs of the business and our customers.
To coordinate and manage Quality and Procedural Documents in the Quality Management System (QMS) including coordination of their review, approval and release and decommissioning and archiving.
To assist with management of Quality Issues and to monitor effectiveness of Corrective and Preventive Actions
To provide support during client audits and regulatory body assessments and any follow up activities
To assist in any Quality related tasks as requested by Line Manager
To support the monitoring of staff training and in particular the completion and maintenance of training logs
To contribute to the Quality strategy from time to time
To act as a Data Protection Officer (DPO) for ESMS and advise on data protection matters to both ESMS staff and clients and monitor internal compliance with the GDPR and other applicable standards
Qualifications & Competences
IT skills: proficient in Word formatting (for example: creating templates), Excel, Visio, Power Point
Great attention to detail
Building positive and productive working relationships with colleagues
Strong organisational skills
Able to adapt to changing situations
Fluent in English
Ability to work independently
Type of Employment – Full Time.
Location – London Office.
Remuneration – Negotiable.
Employee Benefits – Yes.
To provide administrative support to the team providing 24 hour emergency telephone response services, including emergency services to support clinical trials and medical information services on behalf of pharmaceutical companies
To work as a member of a team providing a range of telephone response services including emergency services to support clinical trials, and medical information services on behalf of pharmaceutical companies.
To respond to telephone and email enquiries from a range of service users including healthcare professionals and the public.
To work unsocial hours including nights and weekends, according to a pre-arranged rota.
To take collective responsibility, with the other members of the team, for maintaining 24 hour operation by covering colleagues’ sickness or other absences, and being prepared to change shifts at short notice or work additional shifts if needed to cover leave
To answer clinical trial enquiries and test calls.
To assist with management of physical and electronic files and documents to ensure that the operations team have immediate access to current information to enable them to provide the service.
To assist the team to improve process and systems for information management
To help with general office functions such as booking venues for client meetings, assisting with provision of hospitality, collecting mail.
To attend team meetings and take notes of meetings from time to time as needed.
To participate in an ongoing training programme in order to ensure familiarity with internal procedures and information resources, and to maintain up to date knowledge in the subject areas relevant to the service provided. Most training is done on the job using in house material and attending training sessions provided by clients.
Qualifications & Competences
Educated to degree level in life science*, pharmacy, nursing, or veterinary nursing degree.
Life science = biology, biomedical science, biochemistry, physiology, pharmacology or zoology. Chemistry is acceptable if the candidate has achieved biology at ‘A’ level or equivalent.
Previous work experience preferably gained in the pharmaceutical industry or veterinary sector.
Excellent interpersonal skills including:
Demonstrable ability to communicate clearly, concisely and accurately, both verbally and in writing, and to listen actively.
Ability to communicate with healthcare professionals, service users and clients at all levels
Ability to remain stable and calm under pressure.
Good attention to detail and accuracy, striving for excellence in standards and methods of work.
High level of computer literacy particularly with Microsoft
Proven ability to be self-motivating and self-reliant, to work independently when required, and manage own work priorities and deliver routine work within agreed timelines.
Ability to work in a team, with drive and commitment to achieve team goals.
Resourcefulness, a proactive mindset and can-do attitude. Demonstrable flexibility and adaptability; able to anticipate and embrace change.
Demonstrate enthusiasm for developing your skills and knowledge.
Skills & Desirable Attributes
Pharmacology or toxicology as part of first degree or a proven interest in these subject.
A post-graduate qualification in Information Science.
The ability to speak a foreign language.
Experience in the veterinary sector or in the pharmaceutical industry.
Experience in medical information or drug safety would be particularly useful e.g. as a clinical trial associate within a pharmaceutical company or contract research organisation.
Experience of working in a multidisciplinary team Experience of providing an information service Experience of working under pressure
Some basic understanding of the following:
the Data Protection Act.
Good Clinical Practice; i.e. UK Statutory Instruments SI1031 and SI1928.
external quality standards and how they affect the service e.g. ABPI and PIPA.
Proven ability to work in a high-pressure environment.
Demonstrate awareness of the importance of patient safety and animal welfare.
Confident presentation skills.
Experience of evaluating clinical papers.
Competence in literature searching.
Evidence of innovation and creativity
Willingness to work shifts, including nights, weekends and public holidays and work alone at time.
Willingness to attend off-site meetings or events which may require overnight stays or foreign travel.
Flexibility and adaptability to change work hours at short notice should this be necessary to maintain the service.
Commitment to attend work regularly and on time, including during unsocial hours.
The individual must have good transport links available or have their own transport.