Planning, review & submission of CTD/ACTD/eCTD for export market (Markets will work for Europe / US).Registration/Re-registration/post approval changes application for export market.Resolve the technical query related to product registration/Re-registration/post approval changes.Follow-up and coordination with internal stakeholders.Review of technical documents.Review of artwork and pack insert.Preparation and submission of Product safety update report.

Role & responsibilities l) Perform searches in various databases, short-list relevant patents/applications and prepare patent landscape Reports for identified molecules.2) Perform FTO and infringement analysis.3) Design IP compliant formulation development strategies4) Perform patentability evaluation and drafting patent applications5) Provide Patent, Exclusivity certification for ANDA filing and patent information for ANDASubmissions.6)Prepare response to office action & handle prosecution.7) Coordinate with R&D, other CFTs, external examiners in prosecuting patent applications and help in building patent portfolio.8) Support the product selection & ideation activity by performing comprehensive analysis of the product including Formulation, PKPD, IPR and Technology Transfer9) Provide technical support to legal teams during litigation/patent oppositions. 10 ) Provide strategic Il) inputs to R&D, BD & portfolio team, and identify leverage opportunities for value maximization.11) To frame launch timelines of products for various countries by reviewing the patent landscape and analyzing IP of blocking patents and Exclusivity for commercial launch. 12) Preparing response to the queries raised by clients and Business Development team and internal and external clients.Preferred candidate profile Educational Qualification should be M. Pharma / PhD & LLB.M. Pharm Pharmaceutics.Having 12 to 15 Years Experience.Must Have Experience in New Product Selection & Formulation IPRPerks and benefits As Per Company Standards.

Role & responsibilities:Asst. Officer / Officer - RM Stores Preferred candidate profile:Specify required role expertise, previous job experience, or relevant certifications.Perks and benefits:Mention available facilities and benefits the company is offering with this job.

Role & responsibilities - Review, compile and submit the Application dossiers (ANDA, MAA) to regulatory agencies like US-FDA, EMA, Health Canada, Australia and ROW countries.- Review and approve regulatory CMC documents being generated at R&D and commercial manufacturing facility such as development reports, BMR, BPR, Specifications, method validation reports, process validation reports, stability protocols, stability data etc. and ensure regulatory compliance. - Maintenance of the complete history of each Drug products (Filing history with agencies/customers, amendments).To coordinate in regulatory audits and provide regulatory support. - Coordination with internal and external stakeholders for regulatory filing related documentation.- Communicate the agency's comments/deficiencies to respective in house departments, prepare the response and submit it back to the agency.- Hands on experience of post approval variations and Annual reports.Preferred candidate profile Master of PharmacyPerks and benefits As per Company Standards

Role & responsibilities :- 1) Knowing HPLC/ GC, Dissolution, UV, FT-IR, Potentiometer Troubleshooting, Calibration, Method Validation and Method Development. 2) Perform the analysis individually for In process and stability samples as per plan.3) Follow Good manufacturing practices, Good laboratory practices and Good documentation practices in ADL.4) Method Development of new products for test like Cleaning, Assay, Residual solvent, Dissolution & organic impurities.5) Preparation, storage and usage of Volumetric / Reagent / Standard / Indicator solution.6) Perform the calibration and verification of all instrument / equipment as per calibration scheduled.Preferred candidate profile :-Post Graduation in M.Sc. Analytical Chemistry ./M. Pharma From Pharma Background Industry.Knowing GCMS, LCMS is added advantagePerks and benefits :-As per company

Role & responsibilities 1) Responsible to monitor overall compliance in Research and development. 2) Review documents pertaining to analytical development and formulation development activity for completeness and accuracy as per regulatory requirement. 3) Monitor day to day activity in analytical development laboratory and formulation development for all time readiness. 4) Responsible to monitor project folders and department folders on the common server. 5) Responsible to review method validation/ verification protocol and report, analytical development report, formulation development report and technology transfer documents etc.6) Preparation of standard operating procedure pertaining to Research and development.7) Review and verification of raw data and electronic data generated at analytical development laboratory. 8) Responsible to verify the outside laboratory analysis and ensuring it is within specification. 9) Evaluation of change control and discrepancy with appropriate remedial action. 10) Identified the training needs to the team member and conduct of the GLP Studies. 11) Responsible to maintain the documents with systematic manner pertaining to the Research and development.12) Responsible for issuance, distribution and control of documents pertaining to research and developmentResponsible to perform other duties allotted by reporting Manager as required or necessary. Preferred candidate profile M.PharmaPerks and benefits As Per Company Standard

1) To allocate daily work based on maintenance order.2) To analysis breakdown & finalize the CAPA.3) To analysis LSHS/FO/Water/Spare consumption.4) Facility review & update for audit purpose.5) Utility, HVAC & Water system operation and maintenance reviewing as per audit point.6) To ensure the critical equipment spares as availability and Co Ordinate with engineering store.7) Taken vendor follow-up for work completion.8) To assist in Preparation of SOP’s, PM schedule & Qualification documents for Department.9) Training to be given to subordinate.10) Implementation of safety norms.11) To initiate & implementation ideas with respect to energy conservation.12) To Orient the Engineering Team towards Updated Knowledge for cGMP and Regulatory Norms.13) To ensure the Boiler inspection is carried as per schedule & comply the boiler inspector observation14) Cost management.

Dear Candidates,Greetings of the day! Harman Finochem Limited is an India-based Pharmaceutical Company catering to its clients across the globe, established by Late Mr. Bhupinder Singh Manhas in 1983, our core competencies are in manufacturing and exporting of Active Pharmaceutical Ingredients mainly Metformin HCl, Fenofibrate, Divalproex Sodium, Riboflavin Phosphate Sodium, Glycopyrrolate/Glycopyrronium bromide and more. We have two USFDA approved manufacturing facilities at Shendra & Chikalthana, Aurangabad. We are hiring for "Regulatory Head - API Division" for Shendra, Aurangabad location, who will be responsible for three API units.Role & responsibilities : 1. Responsible to review and submission of DMFs/E-DMFs/CEPs to US-FDA, Europe, EDQM, Health Canada, PMDA, China, Korea, Brazil and Rest of World. 2. Ensuring timely readiness of dossiers for all submissions. 3. Co-ordination with other departments to resolve the issues and queries related to submitted dossiers. 4. Quality and speedy response to the Regulatory agencies queries and Customer queries. 5. Conduct training on DMF compilation, submission and guidelines to build regulatory team of well-rounded professionals 6. Evaluation of manufacturers of staring material & primary packing material for use in Active Pharmaceuticals Ingredient. 7. Monitoring and communicating new and changing regulations to concern Department. 8. Maintenance of DMF fees and facility fees (self-identification) in accordance to GDUFA Evaluation of change controls and other documents. 9. Maintaining self-identification of our facilities & establishment renewal to US FDA. 10. Review and submission to drug listing (Label) of our API to US-FDA. 11. Maintaining the D&B renewal for our facilities. 12. Maintaining the life cycle of submitted DMFs, annual-updates, amendments and variation filings as per the stipulated timeline.Preferred candidate profile :Education : BSc/MScExperience : 16 to 25yrs of experience in API Pharma Industry into Regulated market Good in Team ManagementPerks and benefits :As per company standard

1) To prepare the Standard operating procedure for Engineering Department.2) Operation & Maintenance of Purified Water System, UF, CSRO, HSRO, EDI & Distribution loop system3) Operation & Maintenance of HVAC/AHU system in API Industry, Pressure balancing, Filter cleaning & area validation activity at site.4) To prepare qualification documents DQ/IQ/OQ for the equipment to be install at site. 5) To prepare preventive maintenance schedule for the newly installed equipment.6) To comply the Engineering related points as per cGMP & GDP practices.7) To Orient the Engineering Team towards Updated Knowledge for cGMP and Regulatory Norms.8) To maintain discipline with co-employees & workers.9) To initiate & implementation ideas with respect to energy conservation.10) To allocate manpower as per work priority.11) To ensure the critical equipment spares as availability and Co Ordinate with engineering store.12) To maintain engineering related documents.13) To act as training coordinator.

Role & responsibilities 1) To set up a required assembly for the reaction. 2) To carry out the reactions as per the given process. 3) To carry out literature search for the product if required. 4) To monitor the progress of reaction by TLC or HPLC. 5) To submit the samples to analytical department for the analysis. 6) To use necessary safety equipment while carry out the reaction, workup etc. 7) To calculate the raw material consumptions norms for new products and to revise the costing of existing products as per the changes in raw material cost. 8) To write the experiments in lab note book time to time 9) Develop and optimize the process to meet the require quality and cost 10) To Scale-up of the developed process in kilo laboratory / pilot plant & finally transfer of process to manufacturing plant. 11) To Perform the activities in Chemical Research Development as per GxP. 12 To prepare the documents like Technology transfer documents, SOPs of R&D. 13) To be involved in investigation team for any discrepancy observed in regular products. 14) To maintain good intra and inter departmental co-ordination. Interested Candidates can share resume on: hrnavimumbai@harmanfinochem.com

Dear Candidates, Greetings of the day!M/s. Harman Finochem Ltd. is well established to thrive in the service of contract manufacturing and development - OSD manufacturing facility (USFDA approved) at Aurangabad, having gained the trust of customers over the past few decades for APIs. We are hiring for "Dy. Manager / Manager - Intellectual Property and New Product Selection" for our Formulation (OSD) unit at Shendra, Aurangabad:Role & responsibilities : l) Perform searches in various databases, short-list relevant patents/applications, and prepare patent landscape Reports for identified molecules.2) Perform FTO and infringement analysis.3) Design IP-compliant formulation development strategies4) Perform patentability evaluation and drafting patent applications5) Provide Patent and exclusivity certification for ANDA filing and patent information for ANDASubmissions.6)Prepare a response to office action & handle the prosecution.7) Coordinate with R&D, other CFTs, and external examiners in prosecuting patent applications and help in building a patent portfolio.8) Support the product selection & ideation activity by performing a comprehensive analysis of the product including Formulation, PKPD, IPR, and Technology Transfer9) Provide technical support to legal teams during litigation/patent oppositions. 10) Provide strategic Il) inputs to R&D, BD & portfolio teams, and identify leverage opportunities for value maximization.11) To frame launch timelines of products for various countries by reviewing the patent landscape and analyzing IP of blocking patents and Exclusivity for commercial launch. 12) Preparing responses to the queries raised by clients and Business Development team and internal and external clients.13) Must Have Experience in New Product Selection & Formulation IPRPreferred candidate profile :Experience: - 10 - 15 years in Pharma IndustryQualification: - M. Pharma / PhD & LLB.

Dear Candidates, Greetings of the day!Harman Finochem Limited is an India-based Pharmaceutical Company catering to its clients across the globe, established by Late Mr. Bhupinder Singh Manhas in 1983, our core competencies are in manufacturing and exporting of Active Pharmaceutical Ingredients mainly Metformin HCl, Fenofibrate, Divalproex Sodium, Riboflavin Phosphate Sodium, Glycopyrrolate/Glycopyrronium bromide and more. We have two USFDA approved manufacturing facilities at Shendra & Chikalthana, Aurangabad.We are hiring for "Officer/Sr. Officer" in IT department for Shendra, Aurangabad location: Role & responsibilities : 1. Overall Compliance of IT SOP's.2. Manage End User Support.3. Follow IT SOP's and compliance.4. Server Room Management.5. ISP link Management.6. Vendor Support and Management.7. Printer Management.8. IT Asset Inventory Management.9. Plant support for any issue of software, hardware and network of client and Standalone instrument computer systems.10. To complete IT related log books as per SOP.11. Take Daily, weekly and monthly back-up and retrieval as per SOP.12. Assign the specified and approved rights / privileges to users.13. User account Management as per approved request from QC.14. Provide support in case any Software / Hardware / Network related issue.15. Support to other sites as and when required.Preferred candidate profile :Experience: 2 to 7years in Pharmaceutical IndustryEducation : Any Graduate / BSc IT

Dear Candidates,Greetings of the day!Harman Finochem Limited is an India-based Pharmaceutical Company catering to its clients across the globe, established by Late Mr. Bhupinder Singh Manhas in 1983, our core competencies are in manufacturing and exporting of Active Pharmaceutical Ingredients mainly Metformin HCl, Fenofibrate, Divalproex Sodium, Riboflavin Phosphate Sodium, Glycopyrrolate/Glycopyrronium bromide and more. We have two USFDA approved manufacturing facilities at Shendra & Chikalthana, Aurangabad.We are hiring for "Executive /Sr. Executive" in IT department for Shendra, Aurangabad location:Role & responsibilities :1. Overall Compliance of IT SOP's and support to Audit requirements.2. Manage End User Support3. Server Room Management 4. ISP link Management5. Vendor Support and Management6. Printer Management and Vendor Support Management7. IT Asset Inventory Management8. Tape Library Management and Maintenance9. Plant support for any issue of software, hardware and network of Server, client and Standalone instrument computer systems.10. To do computer system validation of servers, clients and standalone pc at Site.11. To complete IT related log books as per SOP.12. Take care of Chromatography and non-chromatography software & Monitoring. 13. Create new database / projects / folders yearly and monthly in all QC instrument PC.14. Take Daily, weekly and monthly back-up and retrieval of QC instrument PC as per SOP15. Follow IT SOP's and compliance.16. Assign the specified and approved rights / privileges to user17. Disable / delete / modify / deactivate / lock / unlock user account as per approved request from QC.18. Provide support in case of login issue.19. Provide support in case any Software / Hardware / Network related issue20. Implementation and support of new software's and other GxP Software's21. Audit Representation and Support22. Support to other sites as and when requiredPreferred candidate profile Experience: 5to10years of experience in Pharma IndustryEducation : Any Graduate / BSc IT

Academic:1. Should have minimum qualification of M.Sc preferably in chemistry. 2. Minimum 10+ years experience3. Academic career should be good (preferably first class and above)4. Candidate will be preferred having good communication skill and writingJob Profile:Equipment Qualification protocol / report review DQ, IQ, OQ, PQ, FAT & SATShould have knowledge of API process equipment like reactor, centrifuge etc. Equipment URS review,Layout, P & ID reviewHandling of QMS documents Like Change control, Deviations, Incidences, Performing the Investigation using different investigation tools. Performing the Risk Assessment like nitrosamine Risk Assessment, Quality risk Assessment. HVAC Qualification, PP area Qualification.Handling of temperature mapping activities. Facility Qualification

1) To prepare the Standard operating procedure for Engineering Department.2) Operation & Maintenance of Purified Water System, UF, CSRO, HSRO, EDI & Distribution loop system3) Operation & Maintenance of HVAC/AHU system in API Industry, Pressure balancing, Filter cleaning & area validation activity at site.4) To prepare qualification documents DQ/IQ/OQ for the equipment to be install at site. 5) To prepare preventive maintenance schedule for the newly installed equipment.6) To comply the Engineering related points as per cGMP & GDP practices.7) To Orient the Engineering Team towards Updated Knowledge for cGMP and Regulatory Norms.8) To maintain discipline with co-employees & workers.9) To initiate & implementation ideas with respect to energy conservation.10) To allocate manpower as per work priority.11) To ensure the critical equipment spares as availability and Co Ordinate with engineering store.12) To maintain engineering related documents.13) To act as training coordinator.

Role & responsibilities API Production, Shift ChemistPreferred candidate profile MSC, BSC - Organic Chemistry/ BE/ Btech - Chemical

Job descriptionBelow are details for QC candidate to be recruited.Must have 3 to 6 yrs of experience in QCShould handle HPLC / GC instrument.M.Sc or B.Sc with experience also preferred.Should have worked in GLP /GMP environmentMust have experience in API QCShall have knowledge of 21 CFR / CSV / data integrity / validationsShall have knowledge of Method validation / Method transfer

Roles and ResponsibilitiesConduct equipment mapping, PFD review, OEE monitoring, and PID tuning to optimize plant performance.Ensure compliance with safety protocols during all phases of project execution.Collaborate with cross-functional teams to identify areas for process improvement and implement changes.Develop and maintain project schedules, resource allocation plans, and risk assessments.Manage multiple projects simultaneously, ensuring timely completion within budget and quality standards.Desired Candidate Profile5-10 years of experience in chemical engineering or related field (project management).B.Tech/B.E. degree in Chemical Engineering from a recognized institution.Strong understanding of process scaleup, process improvements, and equipment design principles.Proficiency in MS Office applications (Excel) for data analysis and reporting.

Dear All,Greetings for the day!!We have urgent job opening for Safety - Officer, at Harman Finochem Ltd, A-100, Shendra, Chh. Sambhajinagar.Role & responsibilities 1. Monitoring of fire hydrant system.2. Operation and maintenance of all firefighting equipments.3. Updating of records of fire calls and fire protection system.4. Monitoring near miss /unsafe Act/Unsafe condition practices.5. To conduct training of fire protection system.6. Monitoring of Fire detection system.7. Risk assessment, HAZOP study, chemical safety.8. To ensure work permit system.9. Operation & maintenance of fire pump house. 10. Training.11. Project activity.12. To support the audit & legal compliance.13. Maintain PPEs inventory & indenting.14. To support investigate the accidents, near misses, dangerous occurrences, and occupational diseases and recommend action plans for prevention. 15. To support prepared monthly safety report. 16. Having API manufacturing experience Unit Operation. Preferred candidate profile Desired Educational Qualification: BE/ME/ Msc - Environment/ Chemistry & ADIS / PDIS Desired Experience Year- 03 To 08 Years in Pharma API industry /Chemical Industry Note : Those who are from Pharma Industry background can apply, can share CV at amrutar@harmanfinochem.comThanks Amruta Rajput