Aizant

We are seeking a dynamic and detail-oriented Analytical Documentation professional with 2-4 Years of experience to join our growing team. This role is critical to ensuring quality and compliance during the pharmaceutical product development lifecycle. Key Responsibilities 1. To Follow the Departmental SOPs. 2. Preparation of Raw materials, In-process and Finished product specifications and standard test procedures. 3. To review/revise/obsolete the Raw materials, In-process and Finished product specifications and standard test procedures as per requirements. 4. Handling of pharmacopeial updations. 5. Preparation of Regulatory assessment documents required for filing Viz., Elemental impurities assessment, Nitrosamine impurities assessment, Residual solvents risk assessment reports. 6. Handling of Quality notifications like CCNs, Incidents, Events etc., 7. Preparation or revision of Departmental SOP’s and GTPs. 8. Receiving logbooks, SOPs or any issued documents from QA. 9. Ensuring the compliance with respect to good documentation practice and good laboratory practice. 10. To ensure the error free and online documentation. 11. To ensure the archival of completed documents and files. 12. Complete trainings in Eduzen and document control in Docuzen and close the CAPA in Qualzen. Interested candidates can share their resumes to raghuveera.vutla@aizant.com Note: Immediate Joiners are more preferable

Dear All, We are conducting Walk-In Interview on 13th June 2025(Friday) for Quality Assurance and Quality Control( Formulations ) departments. Quality Assurance: AQA - 6-8 Years of experience in Analytical QA IPQA - 2-4 Years of experience in Line Clearance activities for Production, Warehouse and Dispensing of Raw Materials Quality Control: IPFP - 4-5 Years of experience in HPLC, GC, UV, Dissolution and RS. Stability - 4-6 Years of experience in Dissolution, GC, UV and Sample management Raw Materials - 2-3 Years of experience in sampling of Raw and Packing materials Analytical Method Validations - 3-5 Years of experience in Method validations, HPLC and Dissolution instruments Microbiology - 2-3 Years of experience in Environmental monitoring, Culture media preparation and MLT testing Note: Candidates who are unable to attend the interview, can share their resumes to raghuveera.vutla@aizant.com Venue Aizant Drug Research Solutions Pvt Ltd, Sy.No. 172 & 173, Apparel Park Road, Dulapally, Dundigal-Gandimaisamma Mandal, Medchal-Malkajgiri District-500100

We are looking for experienced candidates at our organization which is located at Hyderabad(Ameerpet). What we're looking for: Maintain records of goods received for stores. Maintain Minimum stock for common items. Initiation of PR for required materials. Ensure easy access to retrieve the required materials. Temperature monitoring must be ensured for the storage area. Follow-up and ensure the supply of material as per the schedule mentioned in the purchase order. Receiving materials and dumping in the stores in chronological order. Preparing GRNs for the invoice received. To conduct physical verification on monthly basis. Why Join Us? Be part of a forward-thinking team that values innovation and creativity. Work on cutting-edge projects that blend chemical engineering with advanced computational techniques. Continuous learning environment where you can grow your skills and career. Competitive salary and benefits package. Ready to make a difference in the world of chemical engineering and technology? Apply now and lets innovate together! Interested candidates can share their resumes to raghuveera.vutla@aizant.com Note: Immediate Joiners are more preferable

Responsibilities: This position requires experienced candidates with 4-7 years in Technology Transfer(Formulation). Co-ordinate for preparation of departmental SOPs/Guidelines/Operating instructions. To supervise transfer of batches from lab scale to Exhibit scale/commercial batches at the shop floor and to ensure quality system compliance. To prepare and review of Master Formula Card (MFC), Scale up protocol, Scale up BMR, process validation protocols (PVP), Stability protocols, Process validation report (PVR), Dissolution Profile Protocols (DPP) and Pilot Bio-Batches Documents. To assist in technology transfer of products from FR&D to production. Monitoring of lab scale batches for tech transfer products. Monitoring of Pilot Bio- Batches. Documentation of experiments online in LNBs. Co-coordinating with Cross functional departments i.e. PD, WH, QA, QC, AD, EG, & RA for process execution. Trouble shooting during commercial scale execution. To carry out feasibility trials in FR&D if required. Compilation of all executed batch process documents and analytical documents and assessing the impact on the commercial scale. Co-ordinate to prepare the specifications for raw material, packaging material, in-process, and finished product. Co-ordination with purchase/ sourcing department for procurement of materials. Co-ordination and participation of internal department audits/ sponsor or client audits. Co-ordinate to prepare Product development reports. To develop at least one skill in a year associated with the job. Note: Immediate Joiners are more Preferable

Dear All, We are seeking a highly motivated and talented Analytical R&D Scientist(Injectables) to join our innovative team. The ideal candidate will have a strong foundation in Analytical development and you will play a crucial role in developing new and improved formulations, ensuring product quality, and meeting regulatory requirements. Location: Hyderabad(Dulapally) Required Experience: 3-6 Years Job Responsibilities: 1. To follow the departmental SOPs 2. To ensure the error free and online documentation. 3. To ensure only calibrated instrument /equipment's are used for analysis. 4. To coordinate with supervisor in developing the methods for dissolution, assay by UV/HPLC and RS by HPLC. 5. To coordinate with supervisor in developing the methods for peptide mapping, peptide sequencing, circular dichroism spectroscopy (CD), Fluorescence spectroscopy, SEC-GPC/MALS, NMR and peptide/ proteins sameness study. 6. To perform analysis of development samples for Dissolution, Assay by UV/HPLC and RS by HPLC as per test method. 7. Perform validation of test procedures like Dissolution, Assay, Related substances, Residue and Chiral purity etc., 8. To ensure the instruments/equipment are cleaned after completing the analysis. 9. Receipt and storage of samples/standards. 10. Labeling of standards, chemicals and reagents. 11. Receipt of log books and SOPs from QA. 12. To ensure the GLP compliance in laboratory. 13. Supporting for the installation of instruments and equipment's. 14. To ensure the reference, working standards and impurities are maintained as per GLP. 15. To ensure the archival of completed files and LNB. 16. Assist and/or perform analysis of development samples for water content by KF, LOD and Identification tests as per Analytical Test Method/Standard Test Procedure. 17. Coordinate and assist for timely completion of Instrument calibration and preventive maintenance. Note: Interested candidates can share their resumes to raghuveera.vutla@aizant.com and Immediate joiners are more preferable

Dear All, We are looking for an experienced and highly motivated Material characterization Scientist to join our team. In this role, you will be responsible for the development, validation, and review of material characterization techniques, including X-ray Diffraction (XRD), Polarized Light Microscopy (PLM), Inductively Coupled Plasma Mass Spectrometry (ICP-MS), Atomic Absorption Spectroscopy (AAS), Surface Area Analyzer, Rheometer, Differential Scanning Calorimetry (DSC), Thermogravimetric Analysis (TGA), Ion Chromatography (IC), Particle Size Distribution(PSD) and Gas chromatography mass spectrometry (GC-MS/MS). You will play a key role in advancing the capabilities of these techniques, ensuring their validation and providing expert reviews for research and development projects. Key Responsibilities: Development of Analytical Methods: Lead the development and optimization of material characterization methods using XRD, Surface Area Analyzer, Rheometer, DSC, TGA, IC, PSD, PLM, ICP-MS, AAS, GC-MS/MS and other related techniques. Ensure these methods meet industry standards and project requirements. Validation of Analytical Techniques: Design, execute, and oversee the validation of analytical techniques for accuracy, precision, and reproducibility. Ensure that all methods are compliant with internal and regulatory guidelines. Review of Analytical Data and Reports: Perform critical reviews of experimental data, ensuring results are consistent with scientific principles and project objectives. Provide expert guidance on the interpretation of complex data and trends. Collaboration with CFT Teams: Collaborate with cross-functional teams like formulation development and quality control labs to support material characterization for product development, optimization and release analysis. Continuous Improvement of Methods: Identify and implement opportunities for improving existing analytical techniques. Stay current with advancements in material science and characterization techniques, ensuring that the teams capabilities remain cutting-edge. Documentation and Compliance: Maintain accurate records of all development, validation, and review processes. Ensure that all activities comply with relevant regulatory standards and quality control measures. Troubleshooting and Instrumentation Support: Provide expert troubleshooting support for analytical instruments and techniques. Ensure the proper maintenance and calibration of instruments such as XRD, DSC, TGA, PSD, ICP-MS, AAS, Rheometer, IC and GC-MS/MS. Training and Knowledge Transfer: Lead training sessions for team members and junior scientists on new methods and techniques. Share knowledge on best practices for method development, validation, and analysis. Qualifications: Education: A masters in chemistry, Materials Science or a related field is required. Experience: Minimum of 5 years of hands-on experience with analytical techniques and theoretical knowledge (XRD, DSC, TGA, PSD, Surface Area Analyzer, ICP-MS, AAS, Rheometer, IC, GC-MS/MS). Strong experience in developing, validating analytical methods and release analysis. Interested candidates can share their resumes to raghuveera.vutla@aizant.com Note: Only M.Sc. with Organic Chemistry specialization profiles will be considered

Dear All, We are looking for Nitrosamine exposure candidates who are having an experience of 3-5 Years into the industry. Responsibilities: Lead method development and validation for trace-level detection of nitrosamines and NDSRIs using advanced instrumentation (GC-MS/MS, LC-MS/MS). Perform root cause analysis and establish robust impurity control strategies based on analytical data and scientific rationale. Prepare and review method validation protocols, risk assessment reports, and regulatory documentation for nitrosamine-related investigations. Interpret analytical data in compliance with GLP, ICH guidelines, and regulatory agency expectations. Drive nitrosamine risk assessments for APIs, excipients and finished dosage forms in collaboration with cross-functional teams. Stay up to date with evolving international regulations and scientific guidance on nitrosamine impurities. Provide technical support during regulatory inspections, audits, and client reviews. Mentor junior analysts and contribute to continuous improvement initiatives in laboratory practices. Note: Interested candidates can share their updated resume to sonyjeevitha.degala@aizant.com

Hi Greetings from Aizant Drug Research Solutions Pvt Ltd Currently we are hiring for Manager/Senior Manager-International Business Development for CDMO/Out-Licensing based at our corporate office, Hyderabad If you are interested, please share your profile with below details Pl share resume to : murali.tirumareddi@aizant.com Present CTC Expected CTC Notice Period Re-location to Hyderabad Best Regards Team HR Aizant Drug Research solutions pvt ltd

Dear All, We are looking for a Regulatory Affairs Executive with 2-4 years of experience in pharmaceutical formulations, specifically for the ROW (Rest of World) market . Hands-on experience in the preparation and submission of regulatory dossiers in CTD and ACTD formats for Rest of the World (ROW) markets. Proficient in drafting and submitting responses to regulatory queries within stipulated timelines. Experienced in managing post-approval activities, including renewals and variations. Skilled in handling Drug Master File (DMF) notifications. Adept at reviewing and ensuring the accuracy and compliance of quality documents such as product specifications, stability data, Product Development Reports (PDR), Batch Manufacturing Records (BMR), Master Formula Cards (MFC), and process validation protocols. Interested candidates can share their resumes to raghuveera.vutla@aizant.com Note: Immediate Joiners are more preferable

Dear All, We are seeking a highly motivated and talented Analytical R&D Scientist( Oral Solid Dosages ) to join our innovative team. The ideal candidate will have a strong foundation in Analytical development and you will play a crucial role in developing new and improved formulations, ensuring product quality, and meeting regulatory requirements. Location: Hyderabad(Dulapally) Required Experience: 2-7 Years Job Responsibilities: 1. To follow the departmental SOPs 2. To ensure the error free and online documentation. 3. To ensure only calibrated instrument /equipment's are used for analysis. 4. To coordinate with supervisor in developing the methods for dissolution, assay by UV/HPLC and RS by HPLC. 5. To coordinate with supervisor in developing the methods for peptide mapping, peptide sequencing, circular dichroism spectroscopy (CD), Fluorescence spectroscopy, SEC-GPC/MALS, NMR and peptide/ proteins sameness study. 6. To perform analysis of development samples for Dissolution, Assay by UV/HPLC and RS by HPLC as per test method. 7. Perform validation of test procedures like Dissolution, Assay, Related substances, Residue and Chiral purity etc., 8. To ensure the instruments/equipment are cleaned after completing the analysis. 9. Receipt and storage of samples/standards. 10. Labeling of standards, chemicals and reagents. 11. Receipt of log books and SOPs from QA. 12. To ensure the GLP compliance in laboratory. 13. Supporting for the installation of instruments and equipment's. 14. To ensure the reference, working standards and impurities are maintained as per GLP. 15. To ensure the archival of completed files and LNB. 16. Assist and/or perform analysis of development samples for water content by KF, LOD and Identification tests as per Analytical Test Method/Standard Test Procedure. 17. Coordinate and assist for timely completion of Instrument calibration and preventive maintenance. Note: Interested candidates can share their resumes to raghuveera.vutla@aizant.com and Immediate joiners are more preferable

We're looking for an experienced professional to lead and drive innovative formulation strategies from development to regulatory submissions. Experience: 16-18 Years(Group Lead) Location: Hyderabad(Dulapally) Key Responsibilities: -Lead end-to-end formulation development of OSD products for regulated and semi-regulated markets -Oversee pre-formulation, technology transfer, scale-up, and exhibit batch manufacturing -Collaborate cross-functionally with QA, QC, RA, Production, and Project Management -Ensure timely completion of development milestones and regulatory documentation (CTD/ACTD) -Mentor and guide a team of formulation scientists -Strong knowledge of ICH guidelines, regulatory expectations, and QbD approach -Proven leadership and team management capabilities -Experience in regulated markets (US/EU) preferred Interested candidates can apply share their profile at raghuveera.vutla@aizant.com

We are looking for a highly skilled and experienced Formulation Development Professional with 1113 years of experience in oral solid dosage forms (OSD). Key Responsibilities: -Lead formulation development projects from R&D to commercial scale. -Design and execute formulation strategies for ANDA/CTD/ACTD submissions. -Conduct literature search, pre-formulation studies, and prototype development. -Troubleshoot formulation and process-related challenges. -Work closely with cross-functional teams Regulatory, ARD, QA, QC, and Manufacturing. -Prepare technical documents, development reports, and support dossier preparation. -Manage technology transfer and scale-up activities to manufacturing units. -Ensure adherence to cGMP, ICH, and regulatory guidelines. -Experience in regulated markets (US, EU) is preferred. If you are passionate about innovation in formulation and want to be part of a growing team, we would love to connect! Apply now or send your CV to raghuveera.vutla@aizant.com

Dear All, We are conducting Walk-In Interview on 29th August 2025(Friday) for Quality Assurance and Quality Control( Formulations ) departments. Quality Assurance: Validations - 4-5 Years of experience in Process and Cleaning validations and equipment qualifications Quality Control: IPFP - 4-5 Years of experience in HPLC, GC, UV, Dissolution and RS. Stability - 4-6 Years of experience in Dissolution, GC, UV and Sample management Raw Materials - 2-3 Years of experience in sampling of Raw and Packing materials Analytical Method Validations - 3-5 Years of experience in Method validations, GC and Dissolution instruments GLP - 2-4 Years of experience in management of working and reference standards, HPLC, GC and RS. Material Science Lab - 3-5 Years of experience in XRD, TGA, DSC and ICPMS 2-5 Years of experience in Nitrosamines and NDSRI's and LC-MS Note: Candidates who are unable to attend the interview, can share their resumes to raghuveera.vutla@aizant.com Venue Aizant Drug Research Solutions Pvt Ltd, Sy.No. 172 & 173, Apparel Park Road, Dulapally, Dundigal-Gandimaisamma Mandal, Medchal-Malkajgiri District-500100

Dear All, We are seeking a highly motivated and talented Analytical R&D Scientist( Topicals ) to join our innovative team. The ideal candidate will have a strong foundation in Analytical development and you will play a crucial role in developing new and improved formulations, ensuring product quality, and meeting regulatory requirements. Location: Hyderabad(Dulapally) Required Experience: 4-7 Years Job Responsibilities: 1. To ensure scientifically strong justification for the analytical tasks taken up. 2. To follow the departmental SOPs. 3. To ensure the error free and online documentation. 4. To ensure only calibrated instrument /equipment's are used for analysis. 5. To coordinate with supervisor and lead development of methods for IVRT, IVPT, ex-vivo, assay by UV/HPLC and RS by HPLC. 6. To coordinate with supervisor in developing the methods for residual solvents and other volatile components by GC. 7. To perform analysis of development samples for IVRT, IVPT, ex-vivo, Assay by UV/HPLC and RS by HPLC as per test method. 8. Perform validation of test procedures like IVRT, IVPT, ex-vivo, Assay, Related substances, residual solvents, Residue and Chiral purity etc., 9. To ensure the instruments/equipment are cleaned after completing the analysis and columns are washed to ensure maximum life. 10. Receipt, storage and management of samples/standards. 11. Labeling of standards, chemicals and reagents. 12. Receipt of logbooks and SOPs from QA. 13. To ensure GLP compliance in laboratory. 14. Supporting the installation of instruments and equipment's. 15. To ensure the reference, working standards and impurities are maintained as per GLP. 16. To ensure timely archival of completed files and LNB. 17. Assist and/or perform analysis of development samples for in-process and finished product parameters as per Analytical Test Method/Standard Test Procedure. 18. Coordinate and assist with timely completion of Instrument calibration and preventive maintenance. 19. To participate in formulation development trails. Note: Interested candidates can share their resumes to raghuveera.vutla@aizant.com and Immediate joiners are more preferable

Dear All, Greetings from Aizant Drug Research Solutions!! We are looking for a motivated professional with strong expertise in Cleaning Validation (QA Formulations) to join our Quality Assurance team. The ideal candidate should have hands-on experience in planning, executing, and documenting cleaning validation activities as per regulatory requirements. Experience: 3-5 Years Location: Hyderabad(Dulapally) Department: Quality Assurance(Formulations) Key Responsibilities: -Preparation and review of Cleaning Validation protocols, reports, and risk assessments. -Execution and monitoring of Cleaning Validation studies as per cGMP guidelines. -Identification of worst-case products and development of cleaning validation strategies. -Preparation and review of SOPs related to cleaning and validation activities. -Review of analytical method suitability for cleaning validation. -Handling deviations, CAPA, and change controls related to cleaning validation. -Coordination with cross-functional teams (Production, QC, Regulatory, etc.) for smooth execution. -Ensuring compliance with international regulatory requirements (USFDA, EMA, MHRA, WHO, etc.). -Sound knowledge of cGMP, regulatory guidelines, and risk-based approach to cleaning validation. -Strong documentation and review skills. If interested, please share your updated resume at raghuveera.vutla@aizant.com Note: Immediate Joiners are more preferred