QA Validation Engineer
Merck KGaA Darmstadt, Germany
Bangalore Operations, India
5d ago

A career at our company is an ongoing journey of discovery : our 57,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials.

For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

Your role :

You will be responsible for the guidance and direction of validation projects covering all the Life Science digital products, applications, computerized systems.

In this role you will assist individuals on a site level as well as write computerized systems validation guidance documents on a Life Science scope.

You will provide expert guidance on all aspects of validation and will need to travel to directly assist individuals / site requiring specific support for a limited time during regulatory inspections and / or large projects.

You will review and become an expert in the regulatory guidelines as well as being current on potential changes which may impact the validation requirements.

You will also provide expert guidance during regulatory audits and will provide project management support for projects which don't have site specific support systems in place.

The role of QA Validation Engineer is to provide validation and quality assurance support for computerized systems, digital products, Process Controls systems, software systems, and IT infrastructure that have been newly developed, installed, upgraded, replaced and / or modified for the use in cGMP area.

You will also be interacting cross-functionally with R&D, Project management, IT, Commercial team, Regulatory, Technical services, Hardware team.

  • Computerized systems / digital products / Control Systems / Software / OT (Operational Technology - industrial software) IT Validation / quality assurance : Develop Validation Master Plan / Validation Plan meeting GAMP, QMS (Quality Management Systems), PDP (Product Development Process) and regulatory requirements based on the systems need / scope of target market and internal / external use in GMP area.
  • Lead and perform 21 CFR Part 11, Annex 11, Risk Assessments, Functional risk assessments, Data Integrity Assessments, FMEA to ensure the requirements, controls are captured prior to development and ensure tested system / products met those requirements.

    For cloud-based applications / digital products ensuring the validation / qualification requirements are identified and implemented meeting regulatory requirements.

    Working in new digital / software products validation / qualification following various development life cycle / models (Waterfall, Agile methodologies, product development, rapid application development, iterative development etc.

    Develop validation protocols to test computer system and audit trail review, backup and restore functionality.Develop Validation protocols (IQ, OQ, PQ), Test scripts for established computerized systems / process control systems / new digital products, IT Infrastructure.

    Ability to review URS, Functional Spec, Design Spec, Test Scripts, User Manual for computerized systems, digital products, software applications (for both COTS and new products / solutions for target markets) Execute protocols, test scripts for computerized systems, new digital products, IT applications.

    Develop Test Summary Report, Traceability Matrix, Validation Summary Reports, 21 CFR Part 11 White paper and management of deviation and observation.

    Operational Change Control, including customer complaints handling, periodic review and re-validation of multiple digital products / software applications.

    Lead and participate as auditee presenting / explaining validation and qualification documents / reports to the regulatory, customer auditors and internal / external auditors.

    Ability to handle minimum of three new digital products / software validation activities in parallel with effective time management and planning.

    Create validation schedules, coordinate execution efforts with various stakeholders.Understanding of Quality Risk Management concepts.

    Identify, develop standard operating procedures for validation system / digital products maintenance and operational part.

    Who you are :

    Minimum Qualifications :

  • Bachelor’s degree in chemical, computer science, bio medical, engineering or another life science discipline
  • 7+ years of experience in either a medical device manufacturing or API manufacturing or life science manufacturing
  • 7+years of validations experience including but not limited to computerized systems, IT applications, New digital product validation, facility, manufacturing / packing equipment, process, cleaning, analytical testing
  • 7+ years of experience in handling multiple projects
  • 7+ years of experience in quality assurance
  • Preferred Qualifications :

  • Good written and verbal skills in English.
  • Excellent computer skills, i.e., Project Planning, Word, Excel, Powerpoint, Sharepoint,
  • Experience with GMPs, GCPs, GLPs, GAMP and Part 11 compliance as they relate to qualification of systems in support of validation of processes
  • Knowledge in GAMP requirements and interpretation to implement based on the software category
  • Comfortable in a fast-paced environment with the ability to adjust to changing priorities.
  • Flexible and accountable, Detailed oriented work standards.
  • Travel Requirements : Global travel required based on the need of project and business
  • What we offer : With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons.

    We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life.

    Join us and bring your curiosity to life!

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