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Quality Assurance Expert
2 months ago
Job Overview
Quality Assurance Specialist
About the Role
- We are seeking a highly skilled Quality Assurance Specialist to join our team at SRG, a leading clinical trial manufacturer.
- The successful candidate will be responsible for overseeing the progression and timely execution of quality assurance activities, ensuring compliance with regulations and industry best practices.
Key Responsibilities
- Collaborate with stakeholders to manage deviations, investigations, and corrective actions.
- Oversee the documentation system, including reviewing and approving standard operating procedures, batch manufacturing records, and other controlled documentation.
- Ensure effective management of the document lifecycle, ensuring compliance with regulations and industry best practices.
- Evaluate site compliance and implement improvements through internal audits.
Requirements
- Experience in quality assurance within a pharmaceutical facility.
- Experience with process validation and cleaning validation and verification.
- Experience working on a sterile site would be advantageous.
- Experience managing validation lifecycles from creation to retirement.
- Expertise in equipment, facility, process change management.
- Excellent communication skills, both written and spoken English, and computer literacy.
- Ability to manage your own workload, meet deadlines & prioritize accordingly.
- Good attention to detail and high standards in all work output.
About SRG
SRG is a dynamic and driven company that offers a challenging and rewarding work environment. As a Quality Assurance Specialist, you will have the opportunity to work with a talented team of professionals and contribute to the success of our clinical trial manufacturing business.