We are looking for a highly skilled Quality Assurance Specialist to join our team. In this role, you will be responsible for ensuring the quality and integrity of computer-based systems in a pharmaceutical environment.
You will work closely with project teams to prepare and execute qualification deliverables, including project plans, risk assessments, and verification reports. Additionally, you will review qualification deliverables generated by team members, migrate computer-based lab equipment systems, and provide technical support as needed.
Key Responsibilities:
* Preparation and execution of qualification deliverables (project plan, HLRA, URS, QPlan, IQ, OQ, PQ, ERES assessment and Verification, Q-Report, risk assessment, decommissioning test plan, SOP)
* Review of qualification deliverables generated by project team members
* Migration of computer-based lab equipment systems (Operating System, Data etc.)
* Technical support and troubleshooting
* Project management and coordination
To succeed in this role, you will need to have a strong background in Computer System Validation, GxP methodologies, and experience working in regulated environments. You should also have excellent communication and problem-solving skills, as well as the ability to prioritize and manage multiple demands.
Required Skills and Qualifications:
* Bachelor's degree in a relevant field
* At least 2 years of experience in Computer System Validation
* Knowledge of GxP methodologies and regulations
* Excellent communication and problem-solving skills
* Ability to prioritize and manage multiple demands
Benefits:
* Competitive salary and benefits package
* Opportunities for professional growth and development
* Collaborative and dynamic work environment
* Recognition and rewards for outstanding performance
This is an exciting opportunity for a motivated and experienced Quality Assurance Specialist to join our team and contribute to the success of our organization.