Job Title: Automation QA Specialist
This role is an opportunity to work in a Quality Assurance team and support compliance and continuous improvement across computer systems in a GMP environment.
About the Role:
We are seeking a Senior Associate – Automation QA Representative to join our Quality Assurance team. The successful candidate will be responsible for developing and maintaining QA procedures, policies, and systems for computerized systems.
Main Responsibilities:
* Quality Assurance Oversight: Develop and maintain QA procedures, policies, and systems for computerized systems.
* Regulatory Compliance: Monitor industry regulations and ensure internal processes remain compliant.
* Documentation & Reporting: Maintain accurate records including change controls, deviations, and QA documentation.
* Continuous Improvement: Identify opportunities to improve system quality and process efficiency.
* Training & Development: Provide guidance and training on computer system QA to relevant staff.
Requirements:
* Qualifications: BSc, MSc, or PhD in Science, Engineering, Quality, or related discipline.
* Experience: Minimum of 3 years' QA experience in a biotech, pharma, or medical device setting.
* Skills: Solid knowledge of cGMP, FDA regulations, Data Integrity, and Quality Risk Management.
Further Information: This role involves working closely with Automation, IT, and Manufacturing to support quality across all systems. The ideal candidate will have strong problem-solving, documentation, and collaboration skills.