As International Business Manager, ultimately responsible for generating new revenue and help the company to grow. Following are the major job responsibilities-1. Market Analysis:• Conduct comprehensive market research to identify trends, opportunities, and potential areas for business growth.• Analyze competitor activities and market dynamics to inform strategic decision-making.2. Business Strategy:• Develop and implement business development strategies aligned… Show more As International Business Manager, ultimately responsible for generating new revenue and help the company to grow. Following are the major job responsibilities-1. Market Analysis:• Conduct comprehensive market research to identify trends, opportunities, and potential areas for business growth.• Analyze competitor activities and market dynamics to inform strategic decision-making.2. Business Strategy:• Develop and implement business development strategies aligned with the company's overall objectives.• Identify and evaluate potential business opportunities, including collaborations, licensing, and mergers and acquisitions.3. Partnership Development:• Cultivate and manage relationships with key stakeholders, including potential partners, collaborators, and clients.• Negotiate and structure partnerships and licensing agreements to enhance the company's product pipeline.4. Project Management:• Oversee business development projects from initiation to completion, ensuring timely and successful execution.• Collaborate with cross-functional teams to align business development initiatives with operational capabilities.5. Regulatory Compliance:• Stay informed about relevant regulatory requirements and ensure that business development activities comply with industry standards. Show less

As Senior Project Manager for WHO-PQ, ultimately responsible to manage communication, coordinate knowledge transfer, project goals, data tracking & analysis and maintain a conflict-free project delivery on-time to meet projected business growth.The key responsibilities are as follows-★ Collect and understand the regulations of WHO and other stringent regulatory bodies, guide the team to implement in the production and quality management system, and ensure that all processes in… Show more As Senior Project Manager for WHO-PQ, ultimately responsible to manage communication, coordinate knowledge transfer, project goals, data tracking & analysis and maintain a conflict-free project delivery on-time to meet projected business growth.The key responsibilities are as follows-★ Collect and understand the regulations of WHO and other stringent regulatory bodies, guide the team to implement in the production and quality management system, and ensure that all processes in the production management process have the legal basis for reference.★ Contact WHO and related experts as the general coordinator to develop WHO-PQ Project plan, connect R&D, QC, QA and Production department to implement and supervise according to WHO-PQ rules and requirements. ★ Compile, review and organize PQ documentation (CTD dossier, SMF, WHO-PAR documentation, related declarations etc.) to ensure their compliance and timeliness of submission to WHO.★ In charge of external communication, information transfer, overall audit management, CAPA implementation and participate in on-site GMP inspection as a coordinator. ★ Act as internal auditor of quality system, participate in self-inspection and external audit. Show less

Major Job Responsibility:• Lead to develop and implement departmental strategy for Production & Technology Department (PTD) in order to establish objectives in line with company goal.• Ensure ‘Right to Operate’ through compliance with all applicable GMP, EHS and other global and local regulatory requirements as well as company’s PQS standard. • Responsible for the successful transfer of the manufacturing process (DS & DP) and its validation at the receiving site by ensuring subject… Show more Major Job Responsibility:• Lead to develop and implement departmental strategy for Production & Technology Department (PTD) in order to establish objectives in line with company goal.• Ensure ‘Right to Operate’ through compliance with all applicable GMP, EHS and other global and local regulatory requirements as well as company’s PQS standard. • Responsible for the successful transfer of the manufacturing process (DS & DP) and its validation at the receiving site by ensuring subject matter risk assessment and excellence in execution.•Ensure product market demands are met safely and delivering quality products in adequate time and quantities. Also ensure maximum utilization of resources to supply quality products at lower cost with driving for better efficiency.• Train and lead the employees to ensure maintainance the facility a state of inspection readiness.• Independently manage competing priorities and allocate, adjust and optimize assigned departmental resources. • Identify, design and implement improvements to plant facilities, process and system to minimize safety and quality risk as well as to ensure greater operational excellence.• Apply advanced theory, technical principles, expert judgement and cross-functional expertise to independently address a broad range of difficult problems.• Lead or support quality or safety related investigation using appropriate problem-solving tool to determine the root cause and implement CAPA to prevent recurrence.• Take full responsibility of people management in the Production and Technology Department. Show less

Major Job Responsibilities:1. Responsible for the overall management work of production department. 2. Lead the production team for development of departmental policies, PQS, URS and other related documents for new facility so as to achieve company goal.3. As a member of the site leadership team, advises on key and operations related issues, initiatives and strategy for continuous improving the site operations performance.4. Participate in project feasibility study… Show more Major Job Responsibilities:1. Responsible for the overall management work of production department. 2. Lead the production team for development of departmental policies, PQS, URS and other related documents for new facility so as to achieve company goal.3. As a member of the site leadership team, advises on key and operations related issues, initiatives and strategy for continuous improving the site operations performance.4. Participate in project feasibility study, budgeting, demonstration related to initial plan of project, facility design and equipment selection. In addition, responsible for monitoring the process of project, organizing the control and assessment of technology, quality, safety cost in construction process;5. Responsible for procurement & management of equipment for production department and provide guidance to the commissioning and qualification of equipment and ensure to maintain validated state of facility.6. Participate in the qualification of workshop facilities and utilities, HVAC system, compressed air system, process water system and other is directly related to quality of product.7. Responsible for the feasibility study to transfer product in OSD facility, capacity calculation of equipment, product batch size determination and leading the technology transfer of product to the workshop according to regulatory requirement. 8. According to the company's annual production and operation target and sales forecast, prepare the annual, quarterly, and monthly production plan. 9. Responsible for the review /approval of SOP, BMR, BPR, Protocols, URS & other documents. 10. Organize related trainings for the staffs, strengthen the skill, safety awareness, product quality awareness, production cost awareness of workshop staff.11. Responsible to ensure production of pharmaceuticals in all steps of manufacturing and packaging compliance with cGMP & EHS requirements.12. Ensure audit readiness and any other duties assigned by management Show less

Major Job Description:1. Develop and lead production & warehouse team in order to supply the quality product according to marketing requirements and meeting regulatory and cGMP requirements.2. Check and modify (if required) the design of the facility to make it incompliance with the international regulatory requirements. 3. Analyze resource (man, machine & material) requirement to maintain smooth product supply and raise requisition of resource required with URS. Assess the… Show more Major Job Description:1. Develop and lead production & warehouse team in order to supply the quality product according to marketing requirements and meeting regulatory and cGMP requirements.2. Check and modify (if required) the design of the facility to make it incompliance with the international regulatory requirements. 3. Analyze resource (man, machine & material) requirement to maintain smooth product supply and raise requisition of resource required with URS. Assess the quotation and help the supply chain department by checking comparative study to purchase the equipment, spare parts and other required items.4. Plan to bring the equipment in operation with appropriate documentation (IQ, OQ, PQ & SOP) and actively participate in qualification activity of equipment, utility and facility.5. Identify the requirement of SOP for maintaining cGMP requirement in the production area and warehouse area. Lead the production team and warehouse team to prepare those required SOP and develop format of other document (BMR, BPR, Protocols).6. Prepare production planning as per sales forecast and raise requisition of material (raw materials & packaging materials) accordingly. Ensure smooth product supply as per marketing requirements.7. Investigate the incident / deviation and identify the root cause, perform risk assessment and implement the proposed CAPA for prevention of repetition.8. Prepare and defend all the external audits both local & International and provide feedback based on the observation of audit.9. Review the SOPs, BMR and Protocols of production area and warehouse area.10. Arrange training program for the production & warehouse employees and ensure the effectiveness of those training.11. Ensure safety at work place and strict adherence to standard operating procedures (SOPs) to maintain good housekeeping and cGMP compliance in production area and warehouse area. Show less

Major Job Description:1. Supervise day to day production process and activities of operators, team leaders & packers to meet monthly production target.2. Partcipate in the risk assessment of equipment and process, investigation of incidents/deviations to identify root cause and impact assessment of any change.3. Cooperate QA to implement CAPA and other audit observations.4. Ensure that production process is going on according to SOP and compliance with GMP requirement.5… Show more Major Job Description:1. Supervise day to day production process and activities of operators, team leaders & packers to meet monthly production target.2. Partcipate in the risk assessment of equipment and process, investigation of incidents/deviations to identify root cause and impact assessment of any change.3. Cooperate QA to implement CAPA and other audit observations.4. Ensure that production process is going on according to SOP and compliance with GMP requirement.5. Solve the production problems effectively and ensure production of quality product.6. Ensure proper utilization of man, machine and time to increase productivity.7. Assess the resource needed and raise requisition, assess the quotation and prepare technical comparison study report.8. Preparation and routine revision of departmental documents (BMR, BPR, SOP, EOP, PPS, PQ Protocols) as per requirement.9. Ensure appropriate cleanliness of production floor and equipment during day to day operations.10. Ensure proper management of equipment, tooling and utensils as per instructions. 11. Ensuring area clearance of production area before going to next operation.12. Participate in the emplyee development program and train Operators & Helpers on SOP/EOP/Protocols and basic GMP. 13. Ensure batch production records are filled up in the shop floor at the right first time after each activity.14. Ensure status label for each activity. Show less

Major Job Responsibility-• Day to day supervision of manufacturing process and lead the operators to meet the daily target.• To ensure the GMP compliance at shop floor• Ensure the status label of equipment, tools, utensils, materials and products is up to date and in compliance with requirement.