QMS Process Lead

  • Anywhere

Job Description:

Purpose: The QMS Process Lead is expected to ensure the adherence with cGMP principles and to maintain them in an ‎effective manner. The role holder will be responsible for the compliance of Quality management system (change ‎control) for all Julphar Plants. Having responsibility for change control process including (issuance, assessment, ‎follow up on execution, closure and trending). Moreover, he/she will be responsible to face external quality ‎audits regulatory/customer audits hosting and audit management .To adhere with the cGMP &GDP principles and ‎to maintain them in an effective manner.‎ Key responsibilities & Accountability: Key Responsibilities & Key Result Areas•Ability to present and articulate issues for resolution, communicating regularly with key stakeholders to ‎ensure alignment, provide consultation as a scientific/technical resource for raised changes and projects ‎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.‎•Act as change control process owner to assure system and relevant records meet regulatory guidelines ‎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 program.‎•Review, revise, and approve(if required) change control action plan evidences to ensure appropriate ‎change control execution and closure.‎•Ensure all stakeholders are appropriately assessing the raised change controls and based on risk based ‎approach.‎•Ensure that processes needed for the quality management system are established and maintained.‎•Maintain proper system related KPIs’ and trending in a way that allow continuous improvement culture.‎•Keeps up to date with all relevant regulations (GXP, GMP, ICH, WHO, FDA, ISO etc.); in compliance with ‎regulations.‎•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.‎•Ensure compliance with current GXP guidelines  Qualifications: – Education •Education: 4 years Bachelor degree or Master’s Degree in Pharmacy/Chemistry is mandatory•MBA or MS in Quality Management a plus – Experience: •Experience of minimum 7-10 years in pharmaceutical industry preferably in Quality Management systems ‎in similar organization.‎•Proven experience in sterile ,non sterile operations & change control system management. ‎•Prior experience in handling similar role will ensure better fitment ‎ – Training: Key Competencies: •High on communication and collaboration , having an ability to manage multiple stakeholders at a time•In terms of competency you are highly result oriented with strong sense of accountability & ownership.‎•Excellent communication skills•Business acumen partnered with a dedication to legality.‎•Must be able to manage tasks and priorities and easily adapt to changing situations. ‎•Good command in English (Communicating, writing and speaking)‎ Technical Competencies: •Solid Technical knowledge with strong implantation skill , people management skill‎•In-depth knowledge of the industry’s standards and regulations guidelines excellent knowledge of ‎reporting procedures and record keeping•Methodical and diligent with outstanding planning abilities an analytical mind able to “see” the ‎complexities of procedures and regulations. •KPI management, proven experience in conducting Risk Assessments. ‎•Problem Solving and high agility on taking right scientific decisions

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