Roles and Responsibilities Prepare dossiers for regulatory submissions (ANDA) according to US FDA guidelines. Manage CMC sections of ANDA applications, including formulations and OSD products. Coordinate with cross-functional teams for dossier preparation and submission. Ensure compliance with regulatory requirements throughout product lifecycle management. Maintain accurate records and databases related to regulatory affairs activities.
Roles and Responsibilities Prepare dossiers for regulatory submissions, including compilation of data from various sources into a cohesive document. Review and compile dossiers prepared by others to ensure accuracy and completeness. Coordinate with internal departments (e.g., CMC, Non-Clinical Toxicology) and external vendors/consultants to obtain necessary information for dossier preparation. Ensure timely submission of dossiers to relevant authorities (e.g., FDA, EMA). Maintain accurate records of all correspondence with regulatory agencies. Desired Candidate Profile 5-8 years of experience in Regulatory Affairs or related field (B.Pharma / M.Pharma degree required). Strong understanding of drug regulatory affairs, particularly in Europe market. Proficiency in compilation, dossier preparation, and regulatory submissions.
Role & responsibilities To ensure and maintain the work discipline on shop floor. Planning and execution of monthly manufacturing/packing plan and other manufacturing/packing activities. Responsible for production related tasks including production planning and process control and troubleshooting for achieving the planned periodic schedules. To ensure effective compliance of quality management system as per cGMP and international regulatory requirement in production and ancillary areas. Responsible for implementation of systems, processes and procedures to facilitate smooth functioning of overall operations. To ensure the execution of validated status of the injection facility. To ensure effectiveness of all standard operating procedures, batch document, master documents of production and compliance to documents. Assuring that the department is in compliance with cGMP/regulatory requirement. Co-ordination for new product transfers and thereafter support for process validation Co-ordination with QA for self- inspection and compliance to the audit observation. Responsible for improvement in product yield and productivity. Proper utilization of man and machine and to ensure compliance for documents as per cGMP requirement. To prepare and review capex, user requirement specification etc. To prepare and review MIS report and other related documents of production department as per requirement. To ensure that initial and continuing training of production persons has been performed as per schedule. To confirm the training matrix, training reports of new and existing employees. To ensure scheduled validation of the equipment, calibration of devices and maintenance of equipment. Responsible for planning and implementation of preventative and predictive maintenance schedules. Overseeing the recruitment, performance of subordinates, mentoring/motivating them to improve their contribution levels. Responsible for man management and administrative functions and new Project management. Responsible for implementation of system, processes and procedures to facilitate smooth functioning of overall operations enhance operational efficiency and cost optimization. Market compliant investigation jointly with QA. To comply and ensure the implementation of safety practices. To report that entire daily schedules and executions to the management. Responsible to self Inspection. Review and approval of QMS elements and process documents through Ample logic and EDCS system. Review and approval of RM, PM, consumable and other dispensing activities through ERP system Preferred candidate profile
Roles and Responsibilities Perform calibration, maintenance, and troubleshooting of process instrumentation equipment such as PLCs, SCADA systems, DCS panels, and sensors. Ensure compliance with safety protocols and regulations during instrument maintenance activities. Collaborate with cross-functional teams to identify and resolve issues related to instrumentation system performance. Develop and implement preventive maintenance schedules for instruments and control systems. Provide technical support to operators on instrumentation-related matters. Desired Candidate Profile 8-13 years of experience in instrumentation engineering or a related field. Diploma/B.Tech/B.E. degree in Any Specialization (with M.Tech in Electrical preferred). Strong knowledge of process instrumentation principles, including PLC programming languages like ladder logic, function block diagrams, etc.
Role & responsibilities Prepare and maintain daily, weekly, and monthly MIS reports using advanced Excel. Develop complex Excel formulas , pivot tables, charts, and dashboards to analyze data trends and measure performance. Collaborate with cross-functional teams to gather requirements and design custom reports. Present findings through clear summary tables, graphs, and explanatory notes . Ensure the availability and accuracy of data reports to meet business requirements. Provide insights and recommendations to improve productivity and performance . Build and manage Excel-based tools and applications to automate reporting processes. Support operational MIS and dashboard requirements across business verticals. Preferred candidate profile Advanced Excel: VLOOKUP, HLOOKUP, INDEX-MATCH, Pivot Tables, Charts, Macros, Conditional Formatting, Data Validation, etc. Analytical Thinking: Ability to interpret data and relate it to business objectives. Attention to Detail: High accuracy in reporting and data validation. Communication: Strong verbal and written communication skills. Presentation Skills: Capable of summarizing data insights in PowerPoint and Excel. Client Handling: Ability to interact with stakeholders and understand reporting needs. Qualifications & Requirements: Minimum 1 year of hands-on experience in MIS reporting and Excel-based analysis. Proven expertise in advanced Excel functions and formulas . Familiarity with MS PowerPoint for business presentations. Strong organizational and multitasking skills. Experience in a data-intensive organization is highly preferred. Immediate joiners will be given preference.
1.Equipment Design Reviews, Plant Layout reviews and verified, PFD & P&ID Finalization, Piping Design , Piping Isometrics, Design philosophy Reviews, Project Cost & Time Estimation. 2. Planning and Scheduling of Project Activities, Budgeting, Material Procurement, Inspection, Erection & Commissioning. 3.Managing the installation & commissioning of machines & equipments as part of project & coordination with clients for execution of projects. 4.Coordinating activities including work scheduling monitoring progress of work to ensure timely completion without any cost & time over run. 5.Checking, verifying and recording the received bills from the vendor. 6.Planning and effecting preventive maintenance schedules of Mechanical, Utility, electrical, electronics & pneumatic instruments to increase machine up time/ reliability; thereby accomplishing production targets. 7.Executing cost saving and energy saving techniques/ measures and modifications to achieve Substantial reduction and work within the budget. 8.Drive various projects for enhancing productivity, improving quality, reducing downtime, enhancing safety and energy saving as per plan. 9.Maintaining all relevant records as per ISO, WHO & cGMP standards. 10.To carry out preventive maintenance as per schedule. Analyzing the breakdown cause of the machine and find out the proper remedies to eliminate it. 11.Performing the inventory for the spares. Maintaining minimum spare stock in order to run smooth operation of the plant. 12.Conducting training programs for improving the technical and personnel skills in down the level staff and workers. 13.Checking daily routine work and Maintenance, Operation of BMS, Water System, HVAC System, Boiler and all other utilities. 14.To ensure the proper functioning of EHS and also perform various activities held in EHS department.
Roles and Responsibilities Prepare ANDA dossiers, CMC modules, and submission documents for US FDA approval. Post approval and life cycle management of approved ANDA & suppliment filling. Review and prepare labeling documents (labels, cartons, pack insert) according to US regulations. Develop expertise in various therapeutic areas such as Cardiology, Diabetology, Neurology, Ophthalmology etc. Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Ensure timely submission of applications to USFDA while maintaining high-quality standards. Desired Candidate Profile 8-10 years of experience in Regulatory Affairs with a focus on US market. Bachelor's degree in Pharmacy (B.Pharma) or Master's degree in Pharmacy (M.Pharma). Strong understanding of dossier preparation guidelines for USFDA submissions. Excellent communication skills for effective collaboration with internal stakeholders.
Role & responsibilities Lead Generation & Prospecting: Identify and qualify new business opportunities with pharmaceutical, biotech, and life sciences companies requiring CDMO services. Client Relationship Management: Build and nurture strong, long-term relationships with prospective and existing clients to understand their development and manufacturing needs. Proposal Development: Collaborate with internal technical, project management, and finance teams to develop proposals, quotes, and presentations tailored to client requirements. Contract Negotiation: Lead contract discussions, ensuring alignment between client expectations and company capabilities while maintaining profitability. Market Intelligence: Monitor industry trends, competitive landscape, and customer needs to refine BD strategy and identify growth areas. Sales Forecasting & Reporting: Maintain an accurate sales pipeline, forecast revenue, and report performance metrics to senior leadership. Cross-Functional Collaboration: Work closely with R&D, operations, regulatory, and quality teams to ensure successful onboarding and execution of new projects. Event Participation: Represent the company at trade shows, conferences, and networking events to build visibility and generate leads. Preferred candidate profile Experience of working in 3 to 5 years in US Market Strong expertise in sterile pharmaceutical manufacturing, with 35 years of relevant experience. Bachelors degree in Pharmaceuticals (Masters or MBA preferred). 5+ years of experience in business development, sales, or account management within a CDMO, CMO. Strong understanding of the pharmaceutical product lifecycle, from preclinical development through commercial manufacturing. Proven track record of meeting or exceeding sales targets. Excellent communication, negotiation, and presentation skills. Ability to work independently in a fast-paced, dynamic environment.