Sr Qa Validation Specialist Job In Munster

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.

As a Sr QA Validation Specialist (CSV), a typical day might include, but is not limited to, the following:

1. Managing compliance monitoring of area operations, including trending of failures and evaluating effectiveness of corrective actions.
2. Investigating and troubleshooting problems which occur and determine solutions or recommendations for changes and/or improvements.
3. Reviewing, editing, and approving deviation notifications, investigations, and corrective actions.
4. Reviewing, editing, and approving change control and SOPs.
5. Participating and supporting the Quality Risk Management (QRM) principles in the formal and informal risk assessment initiatives.
6. Supporting the development, review, and approval of Quality Assurance Agreements (QAA), along with the Approved Supplier List (ASL) process.
7. Presenting and/or defending at both internal and external (regulatory) audits and presenting in a "pressure test" scenario the technical area that they are SME.
8. Supporting quality objectives by contributing information on best practices in the industry and providing recommendations on strategic plans and reviews.
9. Staying up to date with current industry trends and regulatory requirement updates and drive changes and improvements based on trends.
10. Presenting project and program status and metrics to Senior Management.
11. Acting as Technical Subject Matter Expert (SME).
12. Leading special projects as assigned.
13. Providing training and mentorship to less experienced personnel.
14. Leading direct reports if required.
15. Some travel may be required (approximately 25%).

This role might be for you if:

1. You have detailed knowledge of 21CFR11 and Annex 11 as well as MHRA, FDA, and WHO data integrity guidelines.
2. You have strong knowledge and experience with Computer Systems Validation and/or IT Auditing.
3. You have an understanding of the interdependencies of change management, deviation, and continuous improvement.
4. You have the ability to define a vision and implement interim milestones.
5. You have the ability to work in a dynamic organization where innovative solutions are required to ensure a high level of quality is achieved within required timelines.
6. You have knowledge of global organizations, process mapping, and process improvement.
7. You have strong knowledge of applicable federal, state, and local regulations, rules, policies, and procedures.
8. You have the ability to capture relevant facts, assess, and decide to execute.
9. You are skilled in analyzing information of considerable difficulty and drawing valid conclusions.
10. You are comfortable navigating ambiguity with the ability to help define actions.

To be considered for this position, you must hold a BA/BS degree. For Senior Specialist: a 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.