Job Description
Working under the Quality Assurance organization this position is responsible for ensuring IT systems, programs and quality events are robust and meet regulatory agency expectations. The position will liaise with the IT and broader QA organizations to ensure all aspects of IT related programs are in compliance with regulatory agency expectations and internal company policies and procedures.
A typical day might include, but is not limited to, the following tasks:
* Managing compliance monitoring of area operations, including trending of failures and evaluating effectiveness of corrective actions
* Investigating and troubleshooting problems which occur and determining solutions or recommendations for changes and/or improvements
* Reviewing, editing and approving deviation notifications, investigations, and corrective actions
* Reviewing, editing and approving change control and SOPs
* Participating and supporting the Quality Risk Management (QRM) principles in the formal and informal risk assessment initiatives
* Supporting the development, review and approval of Quality Assurance Agreements (QAA), along with the Approved Supplier List (ASL) process
* Presenting and/or defending at both internal and external (regulatory) audits
* Supporting quality objectives by contributing information on best practices in industry and providing recommendations on strategic plans and reviews
* Staying up to date with current industry trends and regulatory requirement updates and driving changes and improvements based on trends
* Presenting project and program status and metrics to Senior Management
This role requires a Sr QA Validation Specialist with a detailed knowledge of 21CFR11 and Annex 11 as well as MHRA, FDA and WHO data integrity guidelines. The ideal candidate will have strong knowledge and experience with Computer Systems Validation and/or IT Auditing.
Key skills and qualifications include:
* BA/BS degree
* Minimum of 5 years directly related experience within Pharma or Biotech or equivalent combination of education and experience
* Recent experience in a data integrity role is preferred