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!
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