15Quality Specialist, Product Support
Allstaff Recruitment -Elstree
Salary: £44,400 per annum
Allstaff Recruitment have the pleasure of working with a niche and leading global organisation to recruit a Quality Specialist.
As the Quality Specialist, you will primarily be responsible for the oversight of the NC/CAPA process and procedures relating to the medical/pharma industry and ensuring that the NCs and CAPAs are compliant and that you are effective and efficient in dealing with quality issues.
Your key responsibilities will include:
- Ensure compliance to NC/CAPA processes and procedures
- Responsible for review and approval of NCs and CAPAs, with attention to detail, review for completeness, accuracy, effectivity, and timeliness along with the review and approval of CAPA changes and extension requests
- Develop and deliver training and coaching for new NC/CAPA users on principles and system requirements
- Liaise with relevant functional groups, facilitate and mentor patient specific solutions team members through all stages of the NC/CAPA process
- Contribute in development of optimum future state of the NC/CAPA process for business needs in alignment with Corporate direction with regard to patient specific solutions processes
- Ensure users provide necessary rigor to the electronic NC/CAPA system content including maintenance of a live record with all relevant evidence attached in a timely manner
- Facilitate and coach NC and CAPA teams in the application of problem-solving techniques and promote its uses and development (e.g. human error reduction, 4-D, five whys, etc.).
- Act as a subject matter expert on all patient specific solutions related procedures, ensuring compliance to the relevant procedures and serve as electronic NC/CAPA super-user
- Lead and execute patient specific solutions NC/CAPA review forums
- Liaise with other sites and departments to ensure compliance to global requirements and metrics are achieved
- Provide input and review of patient specific solutions related procedures
- Identify and lead continuous improvement and collaboration opportunities, promoting development and implementation of quality data and reports for the improvement and optimisation of patient specific solutions related processes
- Lead and participate in cross-site and corporate project teams in areas of CAPA and quality system improvement
- Bachelor’s degree in a science, engineering or related discipline. Mechanical or Biomedical Engineering preferred. Advanced degree in a technical discipline preferred.
- 6 years’ experience in medical/pharma industry or equivalent
- Minimum of 2 years’ experience in area of quality systems, engineering, or equivalent experience preferred
- Experience in interacting with regulatory agencies
- Thorough knowledge of U.S., European, and international regulatory industry guidelines/standards and ability to interpret and apply
- Strong knowledge of supporting Quality Systems (audits, management review, quality planning, etc.)
- Must possess strong communication, project management and influencing skills and have the ability to manage multiple tasks simultaneously
- Strong interpersonal skills, with demonstrated ability to manage and interact with multiple stakeholders at different levels and areas of the organisation
- Strong written and oral communication and negotiation skills
- Strong critical thinking skills
- Highly developed problem-solving skills with demonstrated successful resolution of project-level issues
- Strong analytical skills
- Demonstrated ability to successfully manage and complete projects in a matrix organisation
- Demonstrated ability to work independently
- Experience working in a compliance-risk situation with successful outcomes
To apply for the Quality Specialist, please complete your details below and include a copy of your up to date CV.
**Thank you for your interest in this role, your application will now be reviewed by one of our qualified consultants. Due to the high volume of applications Allstaff Recruitment receive, it is with regret we are unable to respond to all candidates directly. However, if you do not hear from us within seven days, you have unfortunately been unsuccessful on this occasion.
Allstaff Recruitment is an Independent Recruitment Specialist acting as an employment agency and an employment business, specialising in permanent, contract and temporary placements across a vast number of industries. If you are looking for Jobs in Bedford, then look no further than Allstaff Recruitment for a variety of different roles across numerous industries. When looking for recruitment in Bedford, Allstaff Recruitment is genuinely interested in both our candidates and clients and aims to find the best match for you. Our ethos is simple: to build long term relationships by offering an exceptional recruitment service at all times. As a member of the REC, Allstaff Recruitment is committed to working to the highest possible standards. **