Product Approvals and Registrations: Managing the submission of applications, documentation, and data to obtain necessary approvals, licenses, and registrations for the organization's products to be legally marketed and sold without any delays. To make sure to receive all the necessary approvals on time. Regulatory Strategy Development: Creating and implementing strategies to navigate regulatory requirements effectively, considering both short-term needs and long-term goals of the organization. Interaction with Regulatory Authorities: Serving as the primary point of contact for communication and interaction with regulatory agencies, addressing inquiries, providing information, and ensuring timely responses to requests. Regulatory Intelligence: Staying up to date with changes in regulations, industry trends, and competitive landscape to inform decision-making and maintain compliance. Risk Assessment and Management: Identifying potential risks related to regulatory compliance and making informed decisions to mitigate these risks while minimizing impact on business operations. Cross-Functional Collaboration: Collaborating with internal departments such as R&D, quality assurance, manufacturing, marketing, and legal to ensure that all aspects of the organization are aligned with regulatory requirements. Labeling and Packaging Compliance: Overseeing the accuracy and compliance of product labeling, packaging, and promotional materials to ensure they adhere to regulatory guidelines. Quality Systems: Ensuring that the organization's quality systems, documentation, and processes align with regulatory expectations, including Good Manufacturing Practices (GMP) and Quality Management Systems (QMS). Clinical Trials Support: Providing guidance and assistance in the preparation and submission of regulatory documents required for clinical trials, including Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications. Post-Market Surveillance: Monitoring and reporting adverse events, product complaints, and other post-market surveillance activities as required by regulations. Training and Education: Conducting training sessions and workshops to educate internal teams about regulatory requirements, changes, and best practices. Audit and Inspection Readiness: Preparing the organization for regulatory audits and inspections, ensuring that all necessary documentation and processes are in place. Regulatory Documentation Management: Maintaining accurate and organized records of all regulatory-related documents and submissions. Advisory Role: Providing expert advice to senior management regarding regulatory implications of business decisions and strategies. Regulatory Compliance: Ensuring that the organization's products, processes, and operations are in full compliance with relevant laws, regulations, and guidelines set forth by regulatory authorities. Overall, the Regulatory Affairs Officer plays a pivotal role in safeguarding the organization's compliance with regulatory standards, maintaining product quality and safety, and supporting business growth within a highly regulated environment.
Key Area Conduct preventive maintenance as per the defined schedule Ensure cost effective and quality products are utilitzed for maintenance Reduce the maintenance general expenses Reduce the unnecessary overtime works Other Area Responsible for all vehicle repair and maintenance and recovery activities with cost effectiveness and in timely manner Responsible to rapair the vehicles with cost-effectiveness and in timely manner and finding out the root cause of vehicle problems to prevent repeated failure from happening again Establish and implement the vehicle preventative maintenance program Train the maintenance staff to be able to provide service at company’s workshop Regular checking of the vehicles with standard checklist and execute maintenance process in accordance with SOPs guidelines Manage to ensure adequate equipment and tools are available for servicing at maintenance department at any time Ensure accurate inventory record of spare-parts and tools Manage the maintenance team to respond and perform repair services at any time at anywhere during and after office hours Search and cooperate with outside workshops(service centers) for cost effectiveness and in time services for major repairs Check the genuine spare-parts and ensure responable price to be used for repair Manage the team to perform proper trouble shooting , problem solving and immediate response to the vehicle problems at any time Follow the standard rules and regulations and maintain the requirements of Quality Management System in accordance with ISO guidelines Ensure the current working procedure are in compliance with specified SOPs Train and supervise the staff of vehicle maintenance department have adequate knowledge of related SOPs and processes in order to comply with quality requirements Perform any other duties as assign by the supervisor
Recruitment & Selection Assist and follow up in required responsibilities and tasks for staff vacancy announcement and recruitment process. Ensures staffing through internal and external recruitment Oversee recruitment and selection processes, including interviewing, and hiring new employees. Compensation & Benefit Coordinate with other departments on HR related issues such as staff leaves, absent, attendance records, resignation and termination. Advising on pay including employee benefits and promotion and other issues on remuneration. Supervisory all regional HR executive, employee payroll, etc. Ensure that payroll functions are performed in accordance with established policies and procedures. Processes employment verification forms and name change, position change, payroll amend packets, etc. To prepare staff payroll, Computer and records payroll data as schedule. And get the approval from Compensation and Benefit Manager. To ensure social security, Income tax fees are paid punctually. Learning & Development Assist to Developing a management trainee program and schedule. Training staff on HR policies and devising programs to promote desired work culture such as cost savings, customer service, compliance and code of ethics. Coordinate in L&D activities such as orientation, Induction, OJT, Product knowledge, Refresher training, etc.…. Establish, Plan, and deliver training occasionally, including induction programs for new hires. Identify training needs of staff in collaboration with management Performs analyzes about the level of employees satisfaction Perform necessary tasks and procedures of staff recruitment as permanent after completion of the probation period. Developing a management trainee program and schedule. Performance Management Prepares job descriptions and employees evaluation sheets Assist in conducting staff performance appraisal and performance assessments. Establishing employees’ relations programs. Compliance the law Ensure the company rules and regulations are followed by all staff and assist in arranging necessary actions to be taken. Prepares reports for the Department of Labor and other state agencies To supervise and report on absenteeism, lateness, Leave, undisciplined and misconduct matters. Ensure that human resource files and records are maintained in accordance with internal audit requirements and Company policies and procedure. Interpreting and notifying employees on employment legislation. To comply with HR policies and procedures of Pacific Medical Industries. Facilitating & Administration Conduct exit interview with resigning staffs. Assist in dispatching HR related internal office memorandum and announcements. Perform necessary arrangements for staff uniform, staff ID card and office equipment. Assist in facilitating HR related personal affairs Assist in distribution of staff uniform. Prepare and maintain requirements for Quality Management System. Prepares other records and reports required Organizes storage and archiving the HR documents Arrange Medical checkup for incoming staff and keep proper record Assist HR Manager in all administrative and human resources tasks (filing, record Leave request, Handover, etc) Others Flexibly perform other activities required according to situation. Establishing employees’ relations programs accordingly on management approval. Perform any other duties as assigned by the supervisor.
• Developing and implementing innovative strategies to streamline factory operations. • Develop, implement and review operational policies and procedures • Screening, recruiting, and provide training to new factory workers. • Collaborating with quality control managers to establish and execute quality control processes. • Ensuring that factory machinery is in good working order. • Analyzing production data to identify and resolve any production issues. • Preparing production reports with root causes analysis and gap closure. • Regularly inspecting finished products to determine whether they meet established quality standards • Motivating factory workers to continually achieve factory targets • Provide inspired leadership for the organization. • Help promote a company culture that encourages top performance and high morale. • Oversee budgeting, reporting, planning, and auditing. • Ensure all legal and regulatory documents are filed and monitor compliance with laws and regulations. • Identify and address problems and opportunities for the company. • Build alliances and partnerships with other organizations.
Factory equipment and facility maintenance Operation and maintenance of diesel generators to ensure a reliable power supply. Operation and maintenance of HVAC units, including Air Handling Units (AHU), Operation and maintenance of the water treatment system for purified water and its pretreatment processes, Planning and performing of preventive maintenance of the equipment All equipment to ensure accurate documentation. Must be able to work effectively in rotating shifts (day/night) to provide continuous operational support
Monthly market research: conduct market price survey monthly, analyze data and market trends to identify potential areas for growth and potential customers Generate leads and opportunities through various channels, including cold calling, networking, and attending industry events. Build a pipeline of prospective clients for further engagement. Build and maintain strong relationships with prospects and existing clients Assist in preparing presentations, proposals, sales reports, quotations for business development matters Coordinate meetings, manage schedules and maintain accurate records of client interactions and business development activities Provide general administrative support to executives and their teams, including managing calendars, scheduling meetings and handling correspondence. Convey the product samples, invoices, and business documents to customers Send off reports and applications to PPRD offices in Yangon and Nay Pyi Taw Cross-sell or up-sell additional products and services offered by the Company. Needs to have a sound understanding of the products and services, excellent presentation, and have strong negotiation skills. Stay alert to new opportunities in the market and represent the company. Driving volume to achieve company goals and objectives Agility, and self-driven to achieve sales targets Report to Business Development Executive and Business Development Manager
1. Convert the policy from top management into the action plan and issued/spread that plan to the associated section. 2. Manage, control, the Drum Factory Production department as the following… (1) Directly supervise and coordinate the activities of production and operating workers. (2) Assign task and follow up the progress of the drum production team to make sure that operate correctly according to the procedures and specific work instruction. (3) Observe ongoing work to ascertain if work is performed according to instructions and will be completed on time. Ensure that all process control reports are properly and timely filled. 3. Ensure that finished products achieve the company’s quality standards. (1) Check product quality according to guide line and quality standard (2) Analyze quality trouble and take preventive measures for the same trouble (3) Maintain proper quality report line to Plant Manager. (4) Manage and perform testing process, equipment and sample control according to work instruction and procedures. 4. Maximize productivity of machinery and workers and coordinate all manufacturing activities and ensure the highest efficiency of a production shift. 5. Solve the problem arising in production shift, following Plant Manager’s instructions. 6. Assist to Plant Manager for implementing the Company’s Policy on safety and health to be ensure the safety standards are met Conduct daily safety checks and complete the checklist reports. Making HSE reports for as per the requirement If any HSE violation and unsafe action or conditions are founded, report and take actions. 7. Manage the job of preventive maintenance and repairs. 8. Other tasks assigned from Plant Manager and any ad-hoc duties assigned
Key Area Achieve monthly average sales target Expend the market share to get sales growth in terms of quantity Reduce trade marketing expenses Get new credit customers and new outlets Increase customer satisfaction to determine the level of customer service delivering Other Area Perform to achieve sales target and to improve sales Perform to expand market share Perform to reduce selling costs and expenses Perform to try to succeed tender in a maximum Train the necessary staffs to be qualified professional person Assist to provide timely and effective solutions aligned with clients’ needs Monitor sales team’s performance, analyz sales data and report to GMs/NSM Assist in preparing to produce management reporting Ensure to prepare yearly customer satisfaction survey and perform necessary actions Understand and follow Company’s Quality Policy Prepare required actions recommended by internal audit team and ISO auditor and CAPA action in designated time cooperate with QMS team to maintain ISO quality standard. Accountable to meet at least 70% sales target achievement Accountable to build and maintain rapport with key customers; identifying new customer opportunities, increase the credit customers base on yearly target and activate inactive-customers Promote sales growth while minimizing the sales related expanses Promote tender sales growth from the Government and Public/Private Hospital region wide
Receive and test the samples (Raw Materials/ Primary Packing Materials/ Finished Product samples and study samples) according to relevant Pharmacopoeia and approved ATR/ SOPs/ Protocols Plan, prepare protocol and monitor for environmental monitoring sampling and testing in line with protocol and schedule Reporting the EM results and monitoring the trend of results Daily/ weekly/ monthly purified water sampling and testing according to the approved protocol and/ or plan Prepare the SOPs for related activity, instrument's operation and calibration Understanding and following department SOPs Understanding and following the equipment SOPs Participate in calibration and qualification of laboratory equipment Maintaining cleanliness of equipment and working area Prepare and maintain test report according to GDP Good Attitude and need to be enthusiastic work with Team Perform the other related duties as assigned.