About this role
ROLE: Responsible for providing quality systems support for to all processes related to QMS. Assures that quality standards are maintained and assist with the implementation and compliance of the quality management program. Support company goals and objectives, policies and procedures, quality systems, and FDA regulations Employees are expected to support the quality concepts inherent in the business philosophies of Biotech Europe Meditech Inc Ltd, including a variety of job related tasks which may not be specific to this position profile. ESSENTIAL JOB DUTIES AND RESPONSIBILITIES Quality Systems Complaints / CAPA / NCRs Manage the recording, investigation and resolution of product complaints, product problems, or safety issues. Coordinate and maintain the Corrective Action Program to assure appropriate investigation and implementation. Run regular Complaint, CAPA, NCR and continuous improvement monitoring meeting Generate KPI data around Complaint, CAPA, NCR and continuous improvement Validation support Provide support to the Quality Engineering and Operations functions including Risk Assessment reviews and updates. Ensures that all deviations to protocols and/or deviations to acceptance criteria are adequately controlled, documented and addressed by the Validation Project Team. Environmental and testing Co-ordinate the environmental monitoring activities of the contractors Manage in process bioburden / Microbial ID monitoring Ensure all environmental metrics are maintained up to date Regulatory Affairs Support Provide support to Biotech RA with all international country submissions Provide support to solve and reply to any regulatory query. Help to manage and maintain all RA documentation including Technical Master File Operational Support Support the preparation of change notifications/Validation protocols and Reports. Support sterilisation validation / revalidisation Provide ongoing manufacture support to help the team meet its business objectives. Provide Quality role in new product introduction and transfers to production. Customer service - Internal: Develop harmonious working relationships with all functions, and ensure employees have the necessary information (data analysis) and resources to effectively perform their jobs. EDUCATION: School education level University / technical college education level EXPERIENCE: Previous work experience in a similar work environment is essential. COMPETENCIES REQUIRED: Experience in working in High Volume Production Facility Strong computer skills - Change control management; design, process and system. Familiarity with ISO quality systems ( ISO13485 – 21 CFR 820) Good customer relation skills Ability to present an independent opinion Good communication and interpersonal skills -communicate highly technical information, both verbally and wri