Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Business Job Title: Quality Systems & Compliance Specialist II Position Summary: Join Thermo Fischer Scientific as a Quality Systems and Compliance Specialist, ensuring compliance with Regulatory GMP’s and corporate requirements, as well as the safety, efficacy and quality of the products produced. Responsibilities Efficiently use available tools (e.g. TrackWise, eDMS, SFLMS, SAP), to support site success in a variety of tasks associated with QS&C responsibilities. As an eDMS author you will prepare GMP documents. As a TrackWise user you will write change controls, and own & progress CAPA and action items to completion. Process ownership of designated QMS process Support risk management, change control, supplier assurance, deviations and CAPA management, document lifecycle, internal audits, training and metrics reporting. Help to maintain a state of inspection readiness As a qualified QSME you will train others in QMS processes, assist in delivery of GMP training & on the job training which may include innovative technologies. Remain up to date with Corporate and regulatory cGMP requirements Working in coordination with internal and external customers ensure key targets and objectives are efficiently monitored and achieved. Participate in the continuous improvement program (PPI), supporting site wide & cross functional projects as well as departmental ones. Embodying the companies 4i values of integrity, intensity, innovation, and involvement you will align with GMP requirements and company rules, policies, and procedures. You will work with and support a diverse, innovative team to implement and maintain effective QMS processes and compliance across the site. As a self-motivated and passionate individual, there really is no limit to the growth and experience on offer and as a global leader, we can offer you all sorts of opportunity. Education & Skills Degree within a scientific subject or equivalent is preferable, although demonstration of suitable experience in a regulated industry (ideally within Quality Assurance) could be acceptable. Experience of working within the pharmaceutical/ biotech/ medical device industry would be advantageous. A strong quality attitude with tenacious attention to detail and proven degree of accuracy A strong understanding of process ownership Well organised, proactive with a dynamic approach to problem solving, challenging assignments & working to critical timelines Excellent interpersonal written & verbal communication skills Independent worker but also a phenomenal teammate Collaborative style, good sense of integrity and compliance Numerate and literate with analytical capabilities Benefits We offer competitive remuneration, attractive shift allowance, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!