Job Description
We are seeking a skilled and detail-oriented QA Validation Engineer to manage and oversee the organization's change control process.
Daily Responsibilities:
* Coordinate and manage the change control process for product and process changes, ensuring all changes are documented, reviewed, and approved according to company procedures.
* Maintain accurate and up-to-date records of all change control activities, including change requests, impact assessments, approvals, and implementation plans.
* Work closely with various departments, including R&D, Manufacturing, Quality Assurance, and Regulatory Affairs, to evaluate the impact of proposed changes and facilitate their implementation.
* Work closely with Technical SME to ensure all tasks are identified and planned appropriately.
* Excellent organizational, communication, and interpersonal skills.
* Proficiency in using change control software and other relevant tools.
* A high level of attention to detail and accuracy in documentation and record-keeping.
Qualifications Requirements & Qualifications:
* Bachelor's degree in engineering/technology discipline.
* A minimum of 1-2 years' work experience in the Medical Devices / Pharmaceutical regulated industry.
* A strong understanding of regulatory requirements and quality management systems.
* Knowledge of change control processes and procedures.
* Attention to detail.
* Strong analytical and problem-solving skills.