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.
• Operate machine • Cleaning of machine • Change Over (assemble & dismantle) • Trouble Shooting • Process Validation • Cleaning Validation • Cleaning of own working area • Recording of entries and reconciliation in batch record • Recording of process related documents • Recording of logsheets • Operate in accordance with SOP and GMP and maintan basic personal hygiene
• Sourcing quotation and good quality materials from different vendor • Negotiation for best price, payment term and Delivery lead time with vendors • Co-ordinate with all user departments for smooth flow of purchase process • Preparation of purchase order & quotation comparison sheet for management review & approval • Prepare payment form for the purchased materials by coordinating with the related departments • Vendor & User Department relationship management • Monitoring project time for purchase activity • Regular update of purchased data base
Job Description Equipment setting, operation and cleaning. Trial batch manufacturing. Adherance to GMP practices as per the organizational policy. Job Requirements Minimum B. S or, diploma in engineering or in pharmacy. Relevant experience in formulation & development is more preferable. Willingness to work flexible hours. Basic operational skill and preferably in pharmaceutical industries
Key Area Completion of the action plan for audit findings with an agreeable timeline Products quality-related complaints are informed to the Client/IBD promptly. Temperature mapping for cold rooms, including under 25’ C and 30’C, is performed yearly. Monitor and Analyze which products are delivered to which customer in case of recall and, inform the customer promptly, and collect the product in an efficient & effective manner. Make sure that there are no critical external & internal audit findings. Other Area Ensure the working procedures comply with specified SOPs, GDP, and ISO requirements. Prepare QMS-related Standard Operating Procedures (SOPs) Keep a record of quality reports and relevant documentation on a daily, weekly, and monthly basis accordingly. Investigate customer complaints, non-conformities issues and report to QA Manager. Follow up on the audit findings, monitor corrective action plans, and coordinate with other departments regarding quality issues. Assist in preparing and providing necessary information and data for management reporting. Assist the QA Manager to ensure warehouses and distribution channels comply with GDP and specified SOPs. Perform quality-related validation processes periodically to meet the specified standard. Perform the trend analysis of pest control and temperature records every month. Verify the stock count of controlled drugs as per the defined interval. Check the quality of incoming product shipments in receiving. Ensure the proper dispatch activities for controlled drugs. Ensure the reverse logistic activities comply with the defined procedure. Complete the quality-related validation process on specified products. Perform any other tasks as assigned by the supervisor.
Develop new technologies, processes and product formulations for solid and liquid dosage form of pharmaceuticals. Projects can range from new product development, current product improvement, and ingredient evaluation. Write, generate and review protocols, development reports, and master batch records. Validate processes, procedures and formulations consistent with GMP requirements Formulate and modify existing formulas to meet regulatory guidelines, cost parameters and claims Collaborate with colleagues to define project scope, timing, product costs Perform other related duties as required
Perform to achieve sales target and sales improvement Communication with key customers such as medical professionals, Department heads, QC heads, purchasers and other authorized persons for promotion and presentation of responsible products in the market Promoting of responsible products in the market, market penetration to sell our products to the right customers in all of the industry Responsibile to increase sales with existing and new customers Preparation of quotations, tender documents, Sales Contracts and Pre-screening of sales contracts activities in accordance with the rules and regulations of the company. Meet at least 80% Sales target achievement Collecting sale orders, prepare sale invoice and follow up for delivery Verify stock available, Monitor stock reserve and stock forecast to ensure product availability Answer customer enquires Follow up and remind to collect money in time Understand and follow the company’s quality policy Ensure to handle the operation of quotations, sales records and official documents Assist in problem solving of high priority/escaladed items Provide all required routine service and business support to existing customers and distributors Work with sales team on competitive issues guarantee the best outcome. Perform any other tasks as assigned by the supervisor and management
MPS & Inventory control, monitor finished goods stock level and manage production sequence to ensure finished good are fulfilled and delivered as customer requirements MRP, Manage & control RM inventory from both oversea local supply Provide weekly production schedule to meet customer requirement and maximize plant utilization Coordinate with oversea and local suppliers to ensure raw material, packaging and raw material are readiness & meet production requirement Provide monthly report for all related activity such inventory, stock movement, production efficiency, facility utilization. Coordinate with all concern party for new product launching and transition plan will be on track with minimize write off Monitor and drive SLOB reduction, control raw material shelf life Analysis and coordinate with sales & marketing team for critical raw-material supply
Manage the remittance operations effectively and efficiently to ensure timely remittance based on trade agreements and payment terms. Ensure correctness and accuracy in preparing and processing Bank Transfer (TT) documents to minimize errors. Manage the remittance operations to prevent companies or groups from suffering any losses due to delays or errors. Ensure 100% accuracy and timeliness in preparing the required data for changing the Bank Name in accordance with Release Order notification (RO) within two working days from the CBM-approved date. Disseminate daily, weekly, and monthly bank statements to relevant account departments. Monitor TT remittances to avoid overdue payments and unnecessary losses. Report the TT remittance status to management. Minimize unnecessary expenses by monitoring and controlling trade-related expenses. Ensure compliance with international trade regulations and anti-money laundering guidelines. Follow rules and regulations and maintain the requirements of the quality management system in accordance with ISO guidelines. Train and supervise the staff of the bank section to gain knowledge of specified SOPs and processes to comply with its requirements. Build and maintain relationships with remittance partners such as banks, suppliers, clients, and service providers. Negotiate contracts and agreements with remittance partners to ensure favorable terms for the employer. Collaborate with internal teams to align remittance activities with overall business goals. Provide excellent customer service to internal and external stakeholders. Resolve customer (both internal and external) issues and complaints promptly and effectively. Perform any other tasks as assigned by management.