IT Compliance Analyst - fixed term 12 month contract opportunity, working for a global Pharma organisation who offers competitive salary and excellent benefits.
Develop and maintain the quality management system to assure compliance with GMP and GDP
Plan, implement and perform internal quality audits
Monitor and report on product non-conformities
Manage and maintain systems for change control, deviation and CAPA
Manage and maintain a system for product complaint handling ensuring timely completion and reporting. If necessary, assist in any product recall
Collect, collate and compile data for periodic product quality reviews, including preparation of reports
Assist in conducting external/supplier audits as required
Review batch release documentation and coordinate correction of any errors
Assist in maintaining the system for document control, so that the current local and regional SOP systems are managed both in hard copy and electronically
Maintain documentation archiving systems
Prepare and maintain GMP documentation such as standard operating procedures
Conduct training sessions on QA systems as required
Contribute to Global Quality goals, projects and initiatives
Processing of Product Returns forms including usage decision
Provide support in the planning and scheduling of laboratory testing
Initiate follow-up action on out of specification materials
Liaise with contractors and the laboratory on sample quantities and sampling frequency
Ensure stability testing is performed in accordance with the requirements of the marketing authorisations
Provide support and advice relating to the manufacturing and technical content of the Company's product licences and submissions
Ensure that the requirements and conditions of the Company's product licences and submissions are reflected in the manufacturing, technical, and testing processes and procedures.
Parkside Recruitment Ltd is acting as an Employment Business in relation to this vacancy. Parkside Recruitment is an Equal Opportunities Employer.