Technical Quality Assurance Specialist

Just Life Sciences ,
Cardiff, South Glamorgan
More Details
Salary: Up to £35,000 per annum

Overview

Just Life Sciences are working with a Global Pharma client who are looking for a Technical Quality Specialist to join the team. Assisting the Quality Management team in ensuring that all activities on different sites are in compliance with current Good Manufacturing Practice standards and in accordance with company policies to meet business requirements. Main responsibilities: Technical/Quality Assurance ? To play a lead role in the interpretation of business and regulatory (EU/US/Japan) guidelines and QA systems for input into compliance enhancement projects for facilities, processes and products, and to approve experimental and validation reports / protocols where appropriate. ? To promote a sense of quality throughout the site departments so as to raise commercial manufacturing performance and eliminate waste caused by unnecessary compliance errors. ? To conduct internal performance audits and follow up actions within site business units. ? To lead nominated regulatory compliance projects and to ensure that the business meets its regulatory commitments through satisfactory completion of these projects. ? To assist in the hosting of Client audits. ? To review non-compliance identified by audit, deviations and complaints, and use technical / professional judgment to make the appropriate product quality decisions (in association with Quality Management), and to initiate and promote quality improvements to prevent re-occurrence. ? To ensure the review and approval of all documentation relating to manufacturing to support their continued processes to meet the business needs. ? To ensure that products were manufactured in accordance with specified requirements and cGMP. ? To play a lead role in the efficient review and approval of batch documentation to ensure deadlines are met and where required, effective and efficient correction of QP review comments. ? To provide statistical trending reports on quality key performance indicators and to initiate corrective and preventive actions based on this data. To generate a monthly report on the key activities and key performance indicators for the area. ? To liaise with the operational groups regarding relevant compliance topics. People Management ? To manage team performance and absence standards, including coaching, counselling and disciplinary measures as required. To conduct performance appraisal and to set targets and objectives for individual members of the group. ? To manage and process all HR and departmental documentation for the team members including; attendance sheets, overtime forms, sickness related documents, absence request forms and annual leave and staff appraisals including 1:1s, probationary reviews and PMRs. ? In conjunction with the Qualified Person, to review the training requirement of the group and to develop training plans and to conduct on-the-job training of the team where required. ? To supervise the work of subordinate roles in the assigned business unit or operational section. Identify self-development needs for future performance and development needs for team members/direct reports. ? Ensure compliance with company policies and procedures and internal and external Health and Safety and Environmental standards for themselves and team members. Experience: ? The job holder will have significant experience in the pharmaceutical industry, with a diverse knowledge of various dosage form manufacturing and experience of staff supervision. ? Experience of working within a Quality Department within a cGMP/pharma environment. ? Excellent written and verbal communication skills are required by the job holder as in the course of the duties. The job holder will need to communicate with personnel outside of the Quality group, with external clients, regulatory bodies and consultants. ? The job holder will need to have excellent analytical problem solving abilities and be able to lead by example and get results through persuasion and co-operation. ? Experience of GMP auditing to relevant quality standards with potential to perform audits. ? People management experience. Education Educated to degree level or equivalent in a science or quality assurance related discipline, and ideally be a member of a professional body as recognised by the UK MHRA. (A lower level aligned qualification plus significant QA pharma industry experience would also be considered). Interested then please email your CV to justyn at justlifesciences dot com

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