Technical Auditor, Quality Assurance
Location
Plymouth Meeting, PA
Level
Senior
Department
Operations
Type
Full - Time
Salary
Job Description
Posted on:
October 20, 2023
This position is responsible for conducting risk-based technology audits with GCP auditor including, but not limited to, product development audits, computerized system audits, vendor qualifications/audits to confirm compliance with quality assurance standards and regulations. The candidate will also be responsible for leading efforts to implement electronic quality management system (eQMS) components and serve as inhouse eQMS expert of audit component.
Responsibilities
- Create a risk-based audit plans for various complex internal and external[PP1] processes and products with ConcertAI audit team members
- Ensuring that audits are conducted as per the audit plan, audit schedule and reports prepared are honest, accurate, impartial, and useful.
- Opening and closing an audit meeting and assisting with follow up audit.
- Confirming CAPA effectiveness and closing out audits
- Building great relationships, learn about business and products and allowing them to achieve the state of enhanced and sustainable Information Resilience.
- Proactively recognize areas of improvements
- Conducts/Coordinates routine and ad-hoc mock inspections / rehearsals
- Provide support for regulatory inspections and sponsor audits
- Responsible leading efforts to implement electronic quality management system (eQMS) components and serve as inhouse eQMS expert
- Establish and utilize eQMS in support of Audit lifecycle
- Support QA team in promotion and assessment of compliance to regulations, guidelines and corporate policies, lead/support in QA initiatives/projects for quality, process improvements
Job Requirements
- Bachelor’s degree education.
- At least 4 years’ industry experience in Information Technology (IT)/ Information Security (IS)
- 2 years + experience in Pharma, specifically GCP
- Experience in auditing IT Infrastructure, prior IT audit experience is must
- Advantageous to be certified Information Security Auditor (such as, CISA)
- Demonstrates a fundamental knowledge of current relevant GXP regulations, guidelines, and related auditing techniques
- Highly proficient with MS Office, project management software.
- Effective problem-solving skills with a demonstrated ability to identify and quickly resolve issues.
- Excellent written and verbal communication and presentation.
- Able to work successfully in a diverse team environment.
