**JOB RESPONSIBILITIES**:1. Audit1.1 Internal Audit- Establish/update a framework for regular internal audits of primary and support processes to ensure regular and comprehensive review and analysis of processes and documents.- Annual internal audit is planned to inform all parties concerned and ensure effective implementation.- Initiate and ensure effective organization of unplanned internal audit.- In collaboration with process responsibility, responsible for formulating solutions and action plans for audit findings.- Ensure regular follow-up of actions.1.2 External Audit- Ensure that the Department knows and prepares for external audits in a timely manner.- Ensure timely action (action plan, responsibility allocation, etc.) based on the conclusions and recommendations of external auditors.1.3 Vendor Audit/Customer Audit- Establish/update the supplier/customer audit framework.- Plan regular audits, inform relevant parties in time and ensure effective implementation.2. Process efficiency2.1 Overall Control and Analysis of Process Efficiency- Monthly review and analysis of KPIs for performance and overall efficiency.3. Manage customer claims related to quality3.1 Audit of customer requirements (on a daily basis); or directly from customers or sales managers- Develop/update non-conforming and CAPA (corrective and preventive measures) procedures.- Ensure the follow-up by all departments. (Regular supervision through quality and management meetings)3.2 Customer needs analysis + solutions to prevent future problems.- Periodically conduct analysis of customer claims for each customer, according to the number of claims, the number of closed claims, the reasons for claims, etc.- Give analysis conclusions and possible solutions during management meetings.3.3 Follow-up the Solution Implementation- Ensure regular (monthly) tracking based on inconsistent closures/follow-up statements of specific customer/product/industry action plans. (Resolve quality problems through quality meetings, action plans, production meetings, communication with customers or during customer audits)4. Verification4.1 Process validation can ensure timely validation process (mainly for- pharmaceutical products or other products in automated processes with low human impact) according to the set requirements and special methods.- Manages a group of Engineers.- Is accountable for the performance and results of a team within own job family.- Adapts business unit, department, site, or sub-function plans and priorities to address resource and operational challenges. Provides technical guidance to employees, colleagues, and/or customers.5. Environmental Compliance- Lead and organize the company's environmental compliance implementation.6. Compliance of company policies and procedures with the law6.1 Audit and formulation of company policies and procedures- Regular review/formulation of company policies and procedures in accordance with standards, customer and legal requirements, as well as process responsibilities.- Ensure that all policies and procedures are consistent6.2 Implementation of policies and procedures, legal requirements.- Ensure full implementation of local and policies and procedures and full compliance with all departmental activities.7. Product documentation and Implementation7.1 Production Documentation- Develop production documents based on quality process production documents and changes.7.2 Files for changing orders- Develop the change order before it occurs.- Check in all contents of the change order and operation list to the KAM.8. Non-conformity management- The management framework and requirements that do not conform to management are put forward. Actions taken to satisfy the following requirements: 1) product specifications; 2) component specifications; 3) procedure requirements; 4) technical specifications.9. Budget- Prepare departmental budgets (based on the framework established by the financial department) to ensure the achievement of departmental goals and recommend approval by the general manager.- Ensure that the activities of all departments are in line with the budget.10. Technological Development Strategy- Develops Strategy on Technological Development (Technological Upgrades, Investment Priorities, Pay-back optimization, etc.) and proposes for approval from General Manager in order to support Short and Long- term Revenue and Profitability Growth.- Ensures effective Implementation of Strategy through Annual Planning of Investments and regular Control of Plan Implementation.11. Improvement and Maintenance of Equipment11.1. Regular Maintenance and Non-Planned Repair of Equipment- Sets up the Framework and Priorities for Cost-Effective Regular Equipment Maintenance and Repair.- Approves and ensures the Plans for Regular Maintenance of all Equipment (as per Suppliers' and Local Requirements) are implemented in order to minimize Equipment Id
