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