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1- Quality Compliance Manager
Job Accountabilities
- Host inspections and approve audit responses
- Contact and respond to all regulatory authorities for any requirements
- Maintain the approval from all authorities by implementing quality culture awareness to ensure readiness for any external inspection
- Review, evaluate and approve all documents generated at the quality compliance department (Complaint, Recall, site master file, SOPs, annual product review, …)
- Review agreements
- Develop and update the quality compliance system and plan for department improvement and follow up on the actual achievement vs. the department KPIs
- Satisfy needs for the customer and coordinate with them efficiently (QC, production, WH, maintenance, validation, QA, regulatory, sales and marketing, other Hikma sites, etc.)
- Supervising the implementation of APM Compliance function plans, as well as ensuring their compliance with APM site rules and policies
- Ensuring that work activities are carried out achieving the pre-set performance goals, and suggesting any necessary actions to the direct supervisor
- Developing the Departments function’s work plan; assigning work activities, projects, and programs, monitoring workflow, reviewing and evaluating work methods and procedures, and directing such activities to serve the Department's goals and plans
- Proposing plans and programs that boost the effectiveness of the departments’ function-
- Hosting Regulatory Authorities and Corporate inspections within APM site, as well as approving all inspection responses
- Perform internal audit for all quality systems and departments
- Participating in quality risk management procedures
- Reviewing and approving documents generated by the department, as well as following up on schedules/plans/ work relevant to the department
- Reviewing and approving deviation, CAPA, and annual product review reports.
- Providing regulatory compliance guidance and policies for the company
- Generating, reviewing, and approving Quality Agreements
- Developing, maintaining, and updating the quality system as per GMP.
- Establishing clearly defined quality assurance standards and procedures based on international guidelines and regulations that ensure compliance of processes with GMP and quality standards
- Performing other duties related to the job as assigned by the direct supervisor
Qualifications:
- BSc in sciences or higher with enough experience in USFDA regulations
preferable if the candidate was working in a USFDA /EU certified pharmaceutical company with at least 3 years of experience as a compliance manager
- Excellent communication and leadership skills
- Computer skills
- Excellent Arabic and English languages
- Full understanding of the regulatory guidelines and latest requirements
- Planning & Organizing Skills
2- Sr. SAP Support Officer - Procure to Pay
Job description:
KEY ACCOUNTABILITIES:
- Facilitate the implementation and support of SAP Procure to Pay and Warehouse Management solutions
- Perform detailed analysis of complex business process requirements and provide appropriate system solutions; identity, interpret, validate and document business requirements
- Facilitate workshops to collect business requirements
- Map business requirements, processes, and objectives; develop necessary solution modifications to satisfy business needs.
- Design, customize, configure and testing of SAP Procure to Pay and Warehouse Management solutions
- Identify gaps, issues and develop workaround solutions
- Act as liaison with business teams for troubleshooting, investigating, analyzing, and solving SAP solution problems
- Handle SAP changes or emergency transports as needed for high priority issues
- Document SAP functional designs, test cases, and test results
- Proactively identify and propose business process and/or SAP enhancements
- Act as a liaison between the business functions and SAP technical team especially for the integrations of SAP with other solutions
- Provide end-user training and support as required
QUALIFICATIONS:
- Minimum 2 years experience in ERP solutions preferred SAP ECC or SAP S/4HANA
- Minimum 1 year of experience in ERP full cycle implementation as well as end-user support
- Strong understanding of procurement, supply chain, and warehouse business processes
- Ability to multitask and manage multiple deliverables and projects at the same time
- Ability to work in a team environment and effectively interact with others
- Must be results-oriented
- Strong verbal and written English Language skills
KEY ACCOUNTABILITIES:
- Gathering and analyzing business/functional requirements and translating them into technical design specifications
- Support the integration projects through various phases from gathering business requirements to go-live and post-implementation support
- Support the assessment of change requests (corrections, enhancements), proposing and developing solutions by using integration tools such as SAP PI/PO & CPI
- Transforming business function requirements into technical program specs to code, test, and debug programs
- Contribute to 3rd level support of SAP PI/PO & CPI systems (Incident Management, Problem Management, troubleshooting, etc.)
- Ensure compliance with the Hikma IT processes
- Create and maintain end-to-end functional/technical designs for interfaces
- Suggest improvements to current operational procedures within the integration environment
- Support setup of governance rules in the integration area
- Act as the technical expert, ensuring quick turnaround in identifying integration issues and providing timely solutions
- Develop, code, document, and execute unit tests, systems, integration, and acceptance tests
- Perform performance tuning to improve system performance over multiple functions
QUALIFICATIONS:
- Minimum 3 years experience in integration platforms preferred SAP PI/PO or SAP CPI
- Very good analytical skills and business process understanding is required
- Knowledge of integration technologies and architecture is required
- Proficient hands-on experience in implementing A2A and B2B solutions using IDOC, RFC, JDBC, File, ABAP Proxy, SOAP, HTTP, REST, SFTP, and JMS adapters, including UDFs coding, development of PI adapter modules & ECC ABAP enhancements. JAVA skills are a plus
- Complete a minimum of 2 full project lifecycle implementations and rollouts
- Experience with EDI implementation and eCommerce is preferred
- Ability to multitask and manage multiple deliverables and projects at the same time.
- Strong verbal and written English Language skills
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