QA Officer (Software Validation - QMS)

Location: Netherlands

SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Medical Devices organisation, based in Noord-Brabant Netherlands.

Role Description

Provide compliance and Quality Management System process improvement support to the E2E Program teams to ensure compliance with optimization and efficiency in E2E processes.

Responsibilities

• Quality Management System Business Process Expert, acting in support of the our clients Healthcare Quality Assurance team and Q&R Business Process Owner
• Participate directly as our clients Healthcare Quality Management System Business Process Expert in “Process Capabilities” deployment programs, in the Idea to Market (I2M), Market to Order (M2O), and/or Order to Cash (O2C) arenas. Ensuring compliance, efficiency and effectiveness of the processes within the our clients Healthcare sector, cross sectors.
• This entails a thorough knowledge, as example, of Design (I2M), Marketing & Brand & Promotions (M2O), Production & Servicing (O2C) and Procurement /Purchasing
• Includes, but is not limited to all Idea to Market (I2M), Market to Order (M2O), and/or Order to Cash (O2C) processes.
• Support cross-Philips setup and deployment of the Quality Management Systems along business model lines as identified by End-to-End teams through the creation of Quality Transition Plan(s) that identifies appropriate Q&R activities to ensure compliance.
• Work with our clients End to End & ARIS process modeling teams, Business Management System and Quality Management System owners, as well as any other stakeholders to ensure new process descriptions and procedures (PDDs – Process Definition Documents) are efficient, effective, and compliant to the applicable regulations
• Work with Software validation teams to ensure fully integrated, validated and compliant Integrated Landscape software application are deployed.

Requirements

1. Thorough understanding of 21 CFR Part 11 & 21 CFR Part 820 and ability to translate this to IT requirements
2. Thorough understanding of GAMP 5
3. Thorough understanding of ISO 13485, ISO 14971, ISO 9001 and ability to translate this to IT requirements
4. Hands on experience with end to end lifecycle of software validation ( Development , Operations/ Maintenance, Upgrade , Retirement)
5. Good Understanding of SDLC, Agile and other development and project management methodologies
6. Comfortable with working across time zones and seniority levels. Will need to be confident to provide guidance to teams.

Desirable Skills
- Knowledge of 21 CFR Part 210 , 211
- Experience in working directly with FDA/MHRA/ TGA/ ANVISA/other regulatory inspections
- Auditing experience , either in supporting or doing audits
- Awareness of Lean methodologies

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Rowin van der Zwaan.