Quality Management Representative (f/m/d)
with experience in the validation of computer-based systems
What we do:

Goodly Innovations is a fast-growing Munich based Augmented Reality software company. A leader in the Enterprise Augmented Reality (AR) field for regulated industries such as Pharma and Biopharma.

We thrive to expand our position from innovative market pioneer to strong market leader.

Our award winning OptiworX AR suite has been developed for complex dynamic multiuser AR scenarios and is being

adopted by international high-profile pharma corporations.

The position is located at our ‘Development Hub’ office in the heart of Munich, where you will work with a passionate team of international colleagues.

What we offer:

• Excellent work atmosphere in an ambitious start-up of senior industry professionals

 Open communication, flat hierarchy in a motivated, multi-national team

 Working at the forefront of AR-technology with lots of space for personal development

What you will be doing:

QMS/Documentation

  Implementation, maintenance, continuous performance monitoring and improvement of our Quality Management System

 Preparing and owning QMS documentation (process descriptions, organizational charts, policies, specifications, work and/or test instructions, test plans, supplier lists, inventories, forms, checklists, templates)

Quality Process

  Monitoring, reviewing, approving internal processes, change requests, CAPAs, verification and validation protocols

  Maintaining and improving product quality by investigating customer complaints, identifying and implementing corrective and preventive actions

  Validating quality processes by establishing and monitoring product quality attributes,

determining operational and performance qualification, collaborating with product

development and quality assurance teams on design review, verification, validation, and risk

management activities

  Providing training, tools and techniques to enable others to achieve quality standards, as well as

acting as a point of contact concerning topics of quality, risks and safety.

  Conducting internal audits and assisting with/orchestrating external audits

  Contact person for qualification measures at our international customers

As Quality Management Representative, you'll need to have:

  3+ years of experience in a quality role in regulated industry (preferably pharma)

  Knowledge of relevant management system requirements (e.g. EN ISO 9001, VDA 6.1, ICH Q10)

  Good knowledge of quality tools and methods (e.g. FMEA, FTA, PDCA, SWOT, 8D Method)

  Confident pragmatic and pro-active approach to deliver quality improvements

  Strong analytical skills and high capability of organization

  Excellent proactive communication and cooperation skills

  Proficient written and spoken English skills

Even better if you have:

  Knowledge of the guidelines for computer-aided systems (GAMP 5, CFR 21 Part 11, EC Directive Annex 11)

  Experience in working in GMP (GxP) regulated environments

  Experience in the qualification of software

  Knowledge of ERP and/or MES systems

Did we spark your interest?

If this sounds interesting, we would love to hear from you. The position is open now.

We look forward to receiving your application including your salary expectations.

Please send your documents to jobs@goodly-innovations.com

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All rights reserved.

+49 (0) 89 649 819 00

info@goodly-innovations.com