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5.0 - 8.0 years
6 - 9 Lacs
indore, hyderabad, ahmedabad
Work from Office
locations:ahmedabad,hyderabad,indore,bangalore - Provision and manage Apigee X and Apigee Hybrid environments across cloud and on-prem infrastructures. - Design, develop, and deploy scalable API proxies to integrate with diverse backend systems. - Implement security protocols including OAuth2.0, API Keys, JWT, and mTLS across API proxies. - Create and manage API Products, Developer Apps, and handle traffic policies like Quota, Spike Arrest, etc. - Monitor and log API traffic using Google Clouds Operations Suite, including Cloud Monitoring and Logging. - Troubleshoot performance, connectivity, and security issues in Apigee and backend integrations. - Provide security advisory and implement threat protection mechanisms in Apigee environments. - Integrate Apigee APIs with GCP services such as Cloud Armor, Cloud Logging, and Operations Suite. - Collaborate with DevOps and security teams to ensure compliance, scalability, and reliability of APIs. - Ensure CI/CD integration for Apigee configurations using tools like Jenkins, Git, and Terraform (if applicable).
Posted 1 week ago
7.0 - 12.0 years
5 - 10 Lacs
visakhapatnam
Work from Office
We are looking for a meticulous Senior Executive or Assistant Manager to lead regulatory filings at Synnat Pharma Pvt Ltd, a rapidly expanding company in the Active Pharmaceutical Ingredient (API) industry. In this pivotal role, you will be instrumental in navigating the complex landscape of pharmaceutical regulations, ensuring our API products meet the stringent requirements of global regulatory bodies, particularly the US FDA. Your expertise will be crucial in preparing and submitting Drug Master Files (DMFs) and eCTD-compliant documentation, managing regulatory inspections, and proactively mitigating regulatory risks. You will collaborate closely with API manufacturing, quality control, and research teams to develop and implement robust regulatory strategies. Responsibilities will also include conducting regulatory audits, ensuring adherence to ICH guidelines, and managing the lifecycle of API products from a regulatory perspective. A deep understanding of pharmaceutical regulations, coupled with the ability to interact with regulatory authorities, will be essential for ensuring compliance and expanding into regulated markets. Job Details: Industry: Active Pharmaceutical Ingredients (API) Department: Regulatory Affairs Role: Senior Executive / Assistant Manager Regulatory Affairs Location: Visakhapatnam Compensation: 5 to 10 LPA Experience: 7 to12 years Employment Type: Full-time Qualification: Bachelors or Master’s degree in Pharmacy, Chemistry, or a related field Responsibilities: Prepare, review, and submit comprehensive regulatory filings including DMFs, variations, and renewals, ensuring compliance with global regulations. Manage the eCTD compilation and submission process for API products, ensuring accuracy and adherence to timelines. Lead documentation preparation for regulatory inspections, responding to queries from authorities. Conduct regulatory audits of API manufacturing processes to ensure compliance with cGMP requirements. Develop and implement CAPA plans to address regulatory gaps or deficiencies. Monitor and track the status of filings, proactively addressing issues to secure timely approvals. Develop regulatory strategies for API products, considering market access requirements and regulatory trends. Identify and mitigate regulatory risks, ensuring compliance with ICH and US FDA guidelines. Provide regulatory guidance and support to cross-functional teams and ensure change control compliance. Manage the regulatory aspects of API product lifecycle from development through commercialization and post-market surveillance. Collaborate with manufacturing, QC, and R&D teams to ensure compliance throughout the product lifecycle. Participate in product recalls, adverse event reporting, and lifecycle management activities. General Expectations and Experience: 7–12 years of proven experience in API Regulatory Affairs Strong knowledge of US FDA regulations, ICH guidelines, and cGMP compliance. Hands-on expertise in DMF preparation, eCTD submissions, and regulatory audits/inspections. Experience in API manufacturing processes and documentation requirements. Excellent communication, documentation, and negotiation skills with regulatory authorities. Proficiency in Regulatory Compliance Management and change control processes.
Posted 2 weeks ago
2.0 - 6.0 years
0 Lacs
karnataka
On-site
As a member of our team, you will be an integral part of our vision to create a global HCM platform and a suite of AI apps that revolutionize talent management. We are seeking individuals who are driven by curiosity, possess expertise in the field, and have the stamina to bring transformation to the space. Your responsibilities will include collaborating with the Product Manager to comprehend business requirements, actively participating in user story grooming and sprint planning, assisting in the preparation of design documents, coding and delivering user stories with unit testing, and staying abreast of new technologies by executing Proof of Concepts. To excel in this role, you should have a minimum of 2 years of relevant experience, a background in agile development environments, proficiency in cloud ecosystems and API products, hands-on experience in backend development using C#, ASP.Net Core, and any RDBMS, adeptness in frontend development using the Angular framework, familiarity with unit testing tools, and a bonus if you have knowledge of enterprise HCM products. Join us in our mission to reshape talent management and be a part of a dynamic team that is driving innovation in the industry.,
Posted 1 month ago
1.0 - 2.0 years
4 - 5 Lacs
Bengaluru
Work from Office
Identify and develop new suppliers for third-party APIs in India. Source APIs based on client requirements while ensuring quality, documentation, and timely delivery. Build strong relationships with API manufacturers, vendors, formulation companies. Required Candidate profile Strong knowledge of API products and chemical/pharma trading environment Excellent sourcing, negotiation, and communication skills Immediate to 30 days preferred.
Posted 1 month ago
6.0 - 10.0 years
0 Lacs
hyderabad, telangana
On-site
As an Apigee Developer, you should have a minimum of 6 years of experience in API Management with Apigee Edge and Apigee X platform. Your role will involve strong business and technical expertise in requirements gathering, encompassing designing, development, implementation, and Exception handling strategies. You should excel in designing API proxies, including API Products, Portals, Apps, Admin functions (such as KVM, Caches, Flow Hooks, TLS keystore Update, Users and Roles creation, Virtual hosts setup). Your responsibilities will include developing and maintaining Apigee API proxies based on consumer requirements, as well as enhancing or supporting existing APIs. You should be adept at creating reusable shared flows for security, transformation, logging, error handling, and possess knowledge of Google Stack driver. Understanding software development processes and utilizing tools like Postman for testing and troubleshooting APIs is essential. Proficiency in developing Rest APIs/Restful Web services is required. You will be expected to conduct requirements gathering workshops, lead the solution design process, and guide technical teams through complex, multi-phased delivery projects. Identifying risks and implementing mitigation measures throughout the project lifecycle will be part of your role. Additionally, mentoring and training the internal team on design and architecture best practices is crucial for this position. Experience with Code, Configuration, and Build management tools like GIT and Jenkins is preferred for this role.,
Posted 1 month ago
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