MSD Quality Assurance Officer 

United Kingdom, England 

467527777

Job Description

• Ensure that all batch related records are reviewed and approved in a timely manner for completeness, accuracy and adherence to Good Documentation Practices (GDP)
• Conduct final review of Seed folders and convey Seeds status to relevant departments
• Communicating with departments with regards to documentation status; maintaining the document management system (MEDS) by assisting with the review and approval stages
• Responsible for the implementation, execution and ownership of Quality Systems, including electronic document management, change control and Deviation/CAPA Management
• Implementation of global and site quality procedures
• Supporting cross-functional departments to assess change control impact and ensuring their timely review, implementation and closure
• Raising non-conformities, technical incidents and taking suitable and appropriate corrective actions
• Participate in RCA investigations, developing robust CAPA’s or change controls to rectify the problem and prevent recurrence
• Mentor and coach stakeholders in cGMP practices to maintain and develop a cGMP environment
• Perform internal audits
• Maintain and promote a state of audit readiness

Qualifications/Skills:

• Experience of working in a cGMP environment and working within a Quality Management System
• Proven industry experience in Quality Assurance within the Pharmaceutical industry; experience with production of a Pharmaceutical product would be desirable
• A working knowledge and practical experience with the regulatory requirements for manufacture of licensed medicinal products
• Internal Audit Experience desirable
• Good communication skills

Closing date for applications: 26th September 2024

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.