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3 Regulatory Testing Jobs

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2.0 - 7.0 years

4 - 9 Lacs

Hyderabad

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About Us Morepen Proprietary Drug Research Pvt. Ltd. (MPDRPL) is a dynamic pharmaceutical R&D organization committed to developing high-quality, affordable generic and novel products for global markets. With a focus on innovation and regulatory compliance, we work in the area of ANDA, NCEs, 50b2, API development and novel polymorphs. Job Roles & Responsibilities Analytical Method Development & Validation: Develop and optimize analytical methods for pharmaceutical compounds using HPLC, GC, UV-Vis, and other analytical techniques. Perform method validation studies including accuracy, precision, linearity, specificity, and robustness testing. Transfer analytical methods between laboratories and ensure successful implementation. Troubleshoot analytical methods and resolve technical issues. Sample Analysis & Testing: Conduct routine analysis of raw materials, intermediates, and finished pharmaceutical products. Perform quantitative and qualitative analysis following established protocols and regulatory guidelines. Execute stability studies and analyze samples at designated time points. Instrumentation & Maintenance: Operate and maintain analytical instruments including HPLC, GC, GC-MS, FTIR, UV-Vis spectrophotometers. Perform routine calibration. Troubleshoot instrument issues and coordinate with service technicians when needed. Ensure proper documentation of instrument performance and maintenance activities. Data Management & Reporting: Analyze and interpret analytical data using statistical methods and software. Prepare technical reports, certificates of analysis, and regulatory submissions. Maintain accurate laboratory records and electronic data systems. Knowledge & Experience Master's degree in Analytical Chemistry, Chemistry, or related field. 2 - 4 years of relevant experience in pharmaceutical, chemical, or analytical laboratory settings. Strong foundation in analytical chemistry principles and techniques. Preferred Qualifications Experience with advanced analytical techniques (DSC, TGA). Previous experience in pharmaceutical or biotech industry. Understanding of stability testing and forced degradation studies. Knowledge of cleaning validation by UV / HPLC. Why Join MPDRPL? Be part of an organization driving cost-effective global healthcare solutions . Work on end-to-end projects from concept to market. Collaborate with experts across departments in a quality-driven, innovation-centric environment . Access to modern formulation laboratories and pilot-scale facilities. Competitive compensation with performance-linked incentives . Professional development and career advancement opportunities . Comprehensive employee benefits including healthcare and retirement plans .

Posted 1 month ago

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9.0 - 14.0 years

12 - 22 Lacs

Navi Mumbai, Mumbai (All Areas)

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Role & responsibilities: Testing the controls from regulatory guidelines/circulars/advisories on IT and Cyber Security issued by RBI, SEBI, NSDL, NPCI, UADAI by identifying the observations based on control implementation & its effectiveness. Follow up with stakeholder to ensure timely testing of regulatory guidelines, legacy Circulars, Advisories, Show cause notice/ Penalties/Displeasures. Prepare Annual testing plan based on Compliance risk and senior management directions. Support IT & InfoSec team during the onsite IT Examination Review conducted by RBI. Conduct Compliance Testing / Review of RAR, RMP & other regulatory observations related to IT, InfoSec & Digital Banking units to ensure that regulatory guidelines are complied with. Coordinate with stakeholder for seeking responses in respect of testing observations, submission of periodic update to ACB, Board and RBI & Follow up for closure of open issues & observations. Review of new product and process notes. Assist in preparation of monthly / quarterly / annual submission to the Board / Audit & Compliance Committee. Automation of testing related to regulations. Compliance Monitoring & Testing. Regulatory inspection & audit management. Preferred candidate profile In depth knowledge of the regulatory environment for the banks in India particularly in IT and Cyber Security Area. Knowledge of all regulatory compliance requirements in IT & Information Security areas. Good knowledge of IT Governance frameworks & Risk Assessment and mitigation. Good understanding of Digital Banking products and regulations pertaining to the same. Good Co-ordination skills. Good research capabilities and intelligent interpretation of regulatory guidelines. Good knowledge of all the elements (commercial, operational) of banking. Demonstrated ability to drive results and be very effective in a startup. Good interpersonal skills.

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10.0 - 18.0 years

30 - 45 Lacs

bengaluru

Work from Office

Expertise in embedded hardware system design. Draft schematics using CAD tools such as Cadence OrCAD, Altium Designer, or DxDesigner. Define PCB layout guidelines and perform PCB layout reviews using Cadence Allegro, Altium,

Posted Date not available

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