A new opportunity has opened for a Quality Assurance Specialist - eCompliance/Data Integrity to join an excellent biotechnology organisation based in Braintree. This role will directly report to the Quality Assurance Lead - Document Control and Quality Standards.
Please note that to be considered for this role you must have the right to work in this location.
- You will work within a multi-disciplinary team to take a leading role in the implementation and establishment of suitable governance processes to assure eCompliance and Data Integrity.
- Act as the QA Subject matter expert in relation to validation of computerised systems and periodic review.
- Lead the site compliance with regards data integrity of the site data, throughout the full lifecycle in adherence to ALCOA+ principles (paper, hybrid and electronic data).
- Assist the Quality Assurance Lead - Document Control and Quality Standards in their capacity as site Data Integrity lead, conducting audits to ensure regulatory and Company requirements are met.
- Support in generation and roll out of training on eCompliance and Data Integrity to site, with targeted training per role/function.
- Support the maintenance of processes, including GMP document control, education and training, needed for successful operation, monitoring, and improvement of the QMS.
- Statistically Analyse data and develop reporting tools that demonstrate the performance of the PQS at Monthly Quarterly and Annual intervals and provide regular reporting to ensure its continuing suitability, adequacy and effectiveness and review and propose improvements.
- Ability to evaluate complex situations and find solutions for them in a professional manner
- Project ownership and pride in its delivery.
- Having a passion for delivering excellent customer service in a cost-effective way.
- Flexibility towards work assignments and new learning.
- Ability to manage multiple and varied tasks and prioritize workload with attention to detail.
- Comfortable operating autonomously once goals and objectives are set.
- Excellent interpersonal, written and verbal communication skills.
- Requires a Degree level in a life sciences discipline.
- Having current and up to date professional knowledge, expertise and best practice.
- Experience working with GMP quality systems in a Phase III / commercial pharmaceutical manufacturing of biologicals, vaccines, cell or gene therapies manufacturing facility.
- Experience working as a quality professional in biologics and preferably cellular and/or gene therapies.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.