Quality Systems & Compliance Officer

Work Schedule

Environmental Conditions

Job Description

Business Job Title: Quality Systems Officer

Position Summary:

Join Thermo Fischer Scientific as a Quality Systems and Compliance Officer, 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 Quality systems and compliance 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.
• 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.

The Quality Systems & Compliance Officer 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 helpful.
• A strong quality attitude with tenacious attention to detail and proven degree of accuracy
• A strong understanding of cGMP & basic QMS e.g. deviations, change control, SOPs.
• An understanding of the expectations of GMP/ DI with respect to GMP records
• 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!