Job Description
As a QA Validation Specialist, you will play a critical role in ensuring IT systems and quality events meet regulatory agency expectations.
This position is responsible for liaising with the IT and broader QA organizations to ensure compliance with regulatory agency expectations and internal company policies and procedures.
Main Responsibilities:
* Liaise with IT and QA organizations to ensure IT-related programs are compliant with regulatory agency expectations and internal company policies and procedures.
* Lead compliance monitoring of area operations, including trending of failures and evaluating the efficiency of corrective actions.
* Investigate and troubleshoot problems that occur and determine solutions for changes and improvements.
* Review, edit, and approve deviation notifications, investigations, and corrective actions.
* Review, edit, and approve change control and SOPs.
* Support Quality Risk Management (QRM) principles in formal and informal risk assessment initiatives.
* Support the development, review, and approval of Quality Assurance Agreements (QAA), along with the Approved Supplier List (ASL) process.
* Present and/or defend at internal and external audits and present technical areas as a Subject Matter Expert.
* Support quality objectives by contributing information on best practices in the industry and providing recommendations on strategic plans and reviews.
* Stay up-to-date with current industry trends and regulatory requirement updates.
Requirements:
* Detailed knowledge of 21CFR11, Annex 11, MHRA, FDA, and WHO data integrity guidelines.
* Solid understanding and experience with Computer Systems Validation and/or IT Auditing.
* Understanding of interdependencies of change management, deviation, and continuous improvement.
* Knowledge of global organizations, process mapping, and process improvement.
* Analytical skills to draw valid conclusions from complex information.
* Ability to navigate ambiguity and help define actions.
Education and Experience:
* Bachelor's degree required.
* 3+ years of related experience for Specialist level.
* 5+ years of directly related experience within Pharma or Biotech for Senior Specialist level.