QMS Assistant Manager

Julphar - UAE

Job Ref. ID: 20256 Job Title: QMS Assistant Manager Division: Quality Compliance Country: UNITED ARAB EMIRATES Work Location: UAE (RAK head office) Job Type: QMS Manager Employment Type: Full Time Employment (Un-limited Contract) Job Description:Purpose: The QMS manager is expected to ensure the adherence with cGMP principles and to ‎maintain them in an effective manner. He/She will be responsible for the compliance of ‎Quality management systems for all Julphar Plants. He/She mainly responsible for ‎CAPA management, handing ISO audits, KPI system, Quality council, Document ‎management systems and handling EQMS/DMS. Moreover, he/she will be responsible to ‎face external quality audits regulatory/customer audits hosting and audit management.‎ Key responsibilities & Accountability: • Ability to present and articulate issues for resolution, communicating regularly with key ‎stakeholders to ensure alignment, provide consultation as a scientific/technical resource ‎for assigned projects, mentor and share experience with colleagues • Ensure compliance with current Good Manufacturing Practices, Good Documentation ‎Practices, applicable ISO standards and other areas of mandatory regulatory oversight.‎ • Provide subject matter expertise to assure CAPA records meet regulatory requirements ‎and industry practices.‎ • Compile and provide analysis and communicate monthly Quality metrics.‎ • Compile and evaluate quality metrics for dissemination at Quality Council and ‎Management Review • Assist with corporate and/or third-party audit and inspection readiness and development ‎of robust inspection readiness • Review, revise, and approve GxP controlled documents to ensure compliance and ‎facilitate continuous improvement • Ensure all processes needed for the quality management system are established and ‎maintained.‎ • Ensure proper control over documentation centre responsible for controlled documents ‎issuance, retention and obsolescence. ‎ • Responsible to CAPA system management, and its effective monitoring.‎ • Keeps up to date with all relevant regulations (GXP, GMP, ICH, WHO, FDA, ISO etc.); ‎makes sure the written procedures (SOPs, instructions) are in compliance with ‎regulations.‎ • Ensure that review, distribution, and control of SOP and technical documents are ‎maintained.‎ • Establish SOP's based on QMS, and revise them as necessary. Manage SOP's based ‎on related procedures • Responsible for ensuring EQMS compliance for record creation ,access levels , and ‎users creation.‎ • Establishes operational objectives and work plans, and delegates assignments to ‎subordinates.‎ Qualifications: - Education Bachelor degree in science / pharmacy/Health care related‎. - Experience: Experience of minimum 7-10 years in pharmaceutical industry preferably in Quality ‎Management systems. And proven experience in Audit & CAPA management. Extensive ‎Knowledge in cGMP and regulatory guidelines.‎ - Training: Key Competencies: Methodical and diligent with outstanding planning abilities an analytical mind able to "see" ‎the complexities of procedures and regulations. Excellent communication skills Technical Competencies: In-depth knowledge of the industry's standards and regulations guidelines excellent ‎knowledge of reporting procedures and record keeping. Business acumen partnered with ‎a dedication to legality.

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