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 processSupport 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 readinessAs 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 requirementsWorking 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 accuracyA strong understanding of process ownershipWell organised, proactive with a dynamic approach to problem solving, challenging assignments & working to critical timelinesExcellent interpersonal written & verbal communication skillsIndependent worker but also a phenomenal teammateCollaborative style, good sense of integrity and complianceNumerate 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!