Role & responsibilities : Lead the sterile API production operations , ensuring all activities align with production schedules and adhere to GMP requirements. Ensure the proper execution of Microbial Limit Tests (MLT) and Bacterial Endotoxin Tests (BET) as part of in-process control and finished product release. Provide technical leadership and troubleshoot any challenges during production to ensure sterile conditions are maintained throughout manufacturing. Implement and manage sterilization processes , including the use of autoclaves and other sterilization equipment, ensuring all systems are validated and functioning optimally. Oversee the execution and analysis of environmental monitoring for contamination control and cleanroom maintenance . Review and approve SOPs, batch records , and technical documentation for sterile operations and testing. Collaborate with Quality Assurance (QA) and Quality Control (QC) teams to resolve any deviations, CAPAs, or issues related to sterility or endotoxin failures . Maintain continuous training programs for the production team on MLT/BET protocols , regulatory updates, and aseptic techniques. Act as a subject matter expert and provide guidance to cross-functional teams on sterile manufacturing practices and testing requirements. Continuously evaluate and improve production efficiencies through lean manufacturing principles and process optimization. Manage compliance with regulatory standards (FDA, EMA, WHO, etc.), ensuring full inspection readiness and the ability to address regulatory concerns effectively. Skills & Competencies: In-depth experience in sterile API manufacturing and understanding of aseptic processing and cleanroom management . Strong knowledge and hands-on experience with MLT (Microbial Limit Testing) and BET (Bacterial Endotoxin Testing) . Deep understanding of GMP, GLP , and regulatory guidelines governing pharmaceutical manufacturing. Experience in troubleshooting and resolving production issues related to sterility and endotoxin contamination. Leadership experience in managing production teams and cross-departmental collaboration. Proven track record in process optimization and driving continuous improvement initiatives. Strong ability to mentor and develop talent within the production department. Preferred Experience: Significant experience in leading sterile production operations for complex formulations or highly regulated products. Exposure to multi-site production and managing scale-up processes for sterile manufacturing. Expertise in regulatory inspections and quality audits (FDA, EMA, etc.). The Senior will oversee and manage the production processes within the sterile API manufacturing facility, ensuring optimal operations while maintaining a high standard of quality and compliance with regulatory standards. The role requires extensive knowledge in Microbial Limit Testing (MLT) , Bacterial Endotoxin Testing (BET) , and comprehensive experience in sterile process management . This person will lead production teams, drive process improvements, and ensure that all operations are carried out in accordance with GMP, SOPs, and international regulations. Why Join Us? Opportunity to lead in a state-of-the-art sterile API facility with cutting-edge technology. Competitive salary and benefits. Be part of a collaborative, quality-driven team focused on delivering life-changing medicines globally.
Job Responsibilities: Should have expertise in understanding business processes Pharmaceutical(API's) and the execution of business unit strategies, along with sales and marketing operations, portfolio management, pricing, key account management, national and international business (regulated and emerging markets). End to End Customers Support to with regard to Enquires, Offers, Sample, Processing Sales orders and receivable management. Develop New Sales opportunities with guidance from the pharmaceutical sales & Business development directors develop new sales opportunities for organization. This work will include web search, contacting via emails, Telephone & Networking. Once contact is established take part in customer visits etc. Handling Customer complaints and co coordinating with Regulatory team to correspond with consultant and Health Authorities concerning deficiencies. Interacting with customer to understand the requirements for registration of new products in their country and coordinating with Regulatory department for required documents. Providing best services and also creating interest to line up more projects with existing customers. Maintaining and updating customer database. Execute Supply agreements and confidential agreement coordinating with client and legal department. Coordinate with teams including R&D, Regulatory Affairs, QA, QC, IPR Excise, Logistics, Finance, and Focus (ERP) on daily basis to build proper communication channel with the clients and maintain productive business relationships. Identify, communicate, coordinate and follow up with buyers and build business relationship with them and Prepare quotations, pricing, negotiate for buyers and claim settlement if any. Attend company stands at exhibitions & Seminars as and when required. Identifying the New Customers and their requirement in the market. Exposure to multiple culture environments through working and travelled on business assignments. Preferred candidate profile: International Sales & Marketing (API's), RUSSIA,LATEM or IRAN markets (Front End Role). Experience 08 to 12 yrs
Role & responsibilities : Should have expertise in understanding business processes Pharmaceutical(API's) and the execution of business unit strategies, along with sales and marketing operations, portfolio management, pricing, key account management, national and international business (regulated and emerging markets). End to End Customers Support to with regard to Enquires, Offers, Sample, Processing Sales orders and receivable management. Develop New Sales opportunities with guidance from the pharmaceutical sales & Business development directors develop new sales opportunities for organization. This work will include web search, contacting via emails, Telephone & Networking. Once contact is established take part in customer visits etc. Handling Customer complaints and co coordinating with Regulatory team to correspond with consultant and Health Authorities concerning deficiencies. Interacting with customer to understand the requirements for registration of new products in their country and coordinating with Regulatory department for required documents. Providing best services and also creating interest to line up more projects with existing customers. Maintaining and updating customer database. Execute Supply agreements and confidential agreement coordinating with client and legal department. Coordinate with teams including R&D, Regulatory Affairs, QA, QC, IPR Excise, Logistics, Finance, and Focus (ERP) on daily basis to build proper communication channel with the clients and maintain productive business relationships. Identify, communicate, coordinate and follow up with buyers and build business relationship with them and Prepare quotations, pricing, negotiate for buyers and claim settlement if any. Attend company stands at exhibitions & Seminars as and when required. Identifying the New Customers and their requirement in the market. Exposure to multiple culture environments through working and travelled on business assignments Preferred candidate profile : International Sales & Marketing (API's), Euroup,US,LATEM Front End Role). Experience 15 to 20 yrs
Roles and Responsibilities Manage domestic marketing activities for API products, including product launches, promotions, and brand management. Develop and execute sales strategies to achieve business objectives in the domestic market. Collaborate with cross-functional teams to ensure effective communication and coordination across departments. Analyze market trends, competitor activity, and customer needs to inform marketing decisions. Ensure compliance with regulatory requirements and company policies. Desired Candidate Profile 8-12 years of experience in Domestic Marketing or related field (API industry preferred). Strong understanding of Active Pharmaceutical Ingredients (APIs) and their applications. Proven track record of success in managing domestic marketing campaigns and achieving sales targets. Excellent communication, leadership, and problem-solving skills.