Quality Assurance Specialist

FULL TIME QA & RA SPECIALIST _IN-VITRO DIAGNOSTIC MANUFACTURING (GENETIC TESTING). SALARY NEG DEPENDANT UPON EXPERIENCE + BENEFITS

THE ROLE

Duties and responsibilities include but are not limited to:

• Support the company Quality Management System (QMS) processes such as Complaints, Non-conformance, CAPA, Change Control and Risk Management processes liaising with internal subject matter experts as applicable.
• ·Support manufacturing and analytical method validation activities as and when required, writing and/or reviewing validation plans and reports as assigned.
• Work with the Development team to ensure smooth and timely introduction of new products, participating in the product design stages including design reviews and product verification and validation for both, reagent kits and bioinformatics pipeline.
• Support external computerised systems validation program.
• Perform internal and external audits as required.
• Prepare EU CE Mark technical documentation, UKCA equivalent and US FDA submissions, and manage the submissions / review processes with the respective competent authorities through to completion (approval, clearance, etc.), as appropriate.
• Manage interactions with competent authorities and/or Notified Body in the territories to effect and maintain regulatory approvals in the markets as applicable.
• Manage Post-market surveillance program, liaising with appropriate stakeholders, and compiling the annual Product Reports for GENinCode assigned products, including those manufactured by external contractors.
• Support Notified Body and Regulatory Authorities inspections.
• Provide guidance to the rest of the organization for effectively implement and ensure compliance with the requirements of the applicable regulatory agencies, standards, and regulations. Ensuring that legislative/regulatory changes are communicated and embedded in the QMS.
• Attend meetings and participate in new projects as designated by line manager.

THE CANDIDATE

You will join the corporate QA & RA team, providing support to all GENinCode sites in UK, EU and US.

You MUST have

• A degree or equivalent in Science.
• Good knowledge of applicable regulations for In-Vitro Diagnostics Devices or Medical Device (software); in particular FDA 21CFR Part 820/Part 11, IVDR and ISO 13485.
• Minimum of 5 years of experience in regulatory affairs for in-Vitro Diagnostics Devices or Medical Device (software).
• Knowledge or at least understanding of Medical laboratories Requirements (ISO 15189)

SKILLS REQUIRED

• Good interpersonal and communication skills. Personable and able to communicate with staff of all levels. Able to work cross-functionally.
• Work effectively, independently and under supervision, being able to adapt to fast pace rapidly changing environment. Flexible approach to work and the tasks to be undertaken.
• Fluent in English (oral and written)_main language used within the company for internal communications and all QMS documents.
• Other EU spoken languages desirable.
• Essential Microsoft Office package knowledge.

THE PACKAGE

• Neg salary subject to experience
• Full Time Permanent Role / flexible working patterns available. Possibility of working from home.
• Occasional travel (10% or less)
• Excellent company benefits.
• Leading genetic testing organisation.

PLEASE NOTE – ONLY SHORTLISTED APPLICANTS WILL BE CONTACTED