QA Compliance Specialist

Job Description

IT Compliance Analyst - fixed term 12 month contract opportunity, working for a global Pharma organisation who offers competitive salary and excellent benefits.

Quality Assurance

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

Quality Control

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

Regulatory

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.