Ahmedabad
INR 20.0 - 30.0 Lacs P.A.
Work from Office
Full Time
Greetings from Kashiv Biosciences!!!! We are looking for Validation and QMS Engineer for our Engineering Team in our Biosimilar Manufacturing facility based out of Ahmedabad. Below are the roles and Responsibilities. Roles and Responsibilities: Responsible for Engineering compliance , Validation and QMS activity. , Timely escalation of any challenge bottle necks pertaining to engineering compliance to the management (site leadership team) to ensure proper planning and solutions. Representing as a Subject Matter Export of Engineering department in front of regulatory auditors. Responsible for engineering investigations pertaining to equipment failures and ensure for proper root cause identification and CAPA effectiveness. Responsible for technical agreements with vendors who have work at Plant premises. Responsible for preparing and review the master list of equipment, instrument along with the preventive maintenance & calibration scheduled. Responsible for change control/deviation management/CAPA Through Track wise management System. Facing the Regulatory, Customer, Internal Audits and preparation of compliance. SOPs and Protocols Training for the new personnel and refreshment training for existing team members. Co-ordination with CFT line Production, QC & QA department to execute any engineering documentation related works. Candidate Details The candidate should be from Pharma industry only having exposure to Parenteral/ Injectables. The candidate should be aware of GDP/ GMP Process. The candidate should have exposure to equipment qualification, Validation and QMS . The candidate should have good communication skills. Interested candidate please share the resume on my mail id manan.hathi@kashivindia.com Regards HR Team Kashiv Biosciences
Ahmedabad
INR 5.0 - 10.0 Lacs P.A.
Work from Office
Full Time
Greetings from Kashiv Biosciences!!! We are looking for Upstream Process Specialist for our Biosimilar manufacturing facility based out of Ahmedabad. Following are the Roles and Responsibilities Roles & Responsibilities Responsible for Upstream Process for Microbial Cell culture and Mammalian Cell culture. Should have exposure on various F ermentation techniques. Qualification and validation of equipment. Exposure to Perfusion process and technique is must. Candidate Details The candidate should have worked in Biosimilars Upstream production(Microbial/ Mammalian Culture) Exposure to Regulatory Audit is Must. Should be aware of QMS Documentation. The candidate should have good communication skills. Interested candidates Please share the resumes at my manan.hathi@Kashivindia.com
Ahmedabad
INR 8.0 - 12.0 Lacs P.A.
Work from Office
Full Time
Greetings from Kashiv Biosciences !!! We are looking for a Chartered Accountant for our Finance and accounts team with the below roles and responsibilities. FINANCIAL REPORTING AND ANALYSIS: Oversee day-to-day accounting activities, such as accounts payable and receivable, general ledger entries. To ensure that transactions are recorded accurately and in compliance with applicable laws and regulations. Responsible for preparing monthly, quarterly, half yearly and annual financial reports including income statements, Balance sheets and Cash flow statements. To ensure compliance with accounting principles and provide accurate financial information for decision-making. Support in the forecasting exercise which includes Forecast P&L (Profit and Loss), Balance Sheet, Cash Flow and other financial reports ACCOUNTS PAYABLE: Oversee all outgoing payments for a business, ensuring timely and accurate processing of invoices and payments, and managing the accounts payable department This role involves supervising & guiding the team members in maintaining records and optimizing cash flow. Creating and implementing reconciliation processes, policies and procedures to improve efficiency and accuracy. TAXATION (DIRECT & INDIRECT): Manages all aspects of a company's tax compliance and planning, ensuring accurate tax returns filing, compliance with regulations, and optimizing tax liabilities. Manage and respond to tax audits, ensuring accurate and timely compliance. Managing all aspects of GST compliance, reconciliation, and GST audit support. Manage monthly, quarterly, and annual tax filings, including TDS and GST. AUDIT :- Manage Tax audits and related co-ordination with the internal & external authorities. Leading audits with team members, ensuring timely completion and adherence to audit procedures. Candidate profile: The person should be from Pharma/ FMCG or any product Based company who can understand the business , vision and Mission of the company The incumbent will be expected to work under accounts and finance team, and will be responsible for Accounting, MIS, Treasury and taxation related responsibilities. Accounting and Auditing Knowledge: Strong understanding of accounting principles, auditing procedures, and regulatory frameworks. Communication Skills: Excellent communication and interpersonal skills to effectively communicate with clients, team members, and senior management. Analytical Skills: Strong analytical skills to review financial data, identify issues, and provide recommendations. Problem-Solving Skills: Ability to identify and resolve issues related to client accounts and audits. Organizational Skills: Strong organizational skills to manage multiple tasks and meet deadlines. Software Proficiency : Familiarity with accounting software (Preference for SAP FI module ) and other relevant tools. Interested Person please share the resume at my mail id manan.hathi@kashivindia.com
Ahmedabad
INR 5.0 - 15.0 Lacs P.A.
Work from Office
Full Time
Greetings from Kashiv Biosciences !!! We are looking for an experienced IP professional with 4-8 years of dedicated experience in patent drafting, prosecution, and analytics in the biotechnology. The ideal candidate should have a strong life science background.(Biotechnology/Microbiology/Biochemistry) and a proven track record of working on patent applications related to biologics, biosimilars, or pharmaceutical technologies . This role will focus on managing patent drafting, global prosecution, freedom-to-operate (FTO) analyses, and supporting IP strategy across the biosimilar pipeline. Key Responsibilities: Patent Drafting & Prosecution: Independently draft and review patent specifications, claims, and responses to office actions (US, EP, IN, and other major jurisdictions). Coordinate with inventors, R&D scientists, and external counsel for t echnical data collection and application filings . Manage timelines and filings for patent applications and ensure procedural compliance. Patent Analytics: Conduct prior art searches, invalidity and opposition searches using databases such as Derwent, Orbit, PatSnap, and Google Patents . Perform patentability assessments, competitive intelligence, and white-space analysis. Freedom-to-Operate (FTO): Perform FTO analysis to identify third-party risks and provide mitigation strategies. Assist in developing IP risk profiles and clearance strategies for biosimilar programs. Portfolio & Docket Management: Maintain and update internal IP records, invention disclosures, and portfolio tracking sheets. Support IP audits and manage annuity tracking in collaboration with the legal and compliance teams. Cross-Functional Collaboration: Liaise with scientific, regulatory, and legal teams to align IP activities with project goals. Summarize complex IP and technical issues clearly for stakeholders across functions. Candidate Details: The Candidate should possess Masters degree in Biotechnology, Microbiology, Biochemistry, or a related life science field. The candidate should have 4-6 years of hands-on experience in patent drafting, prosecution, and analysis preferably i n-house or with a reputed IP law firm . Solid understanding of global patent laws (especially Indian, US, and EP patent practices). Strong scientific and analytical skills with attention to detail. Excellent communication and documentation skills. The candidate should have Passed Indian Patent Agent Examination. The candidate should have Experience with BPCIA framework, EPO opposition, or Indian pre-grant/post-grant opposition. Familiarity with SPCs, PTEs, and exclusivity timelines. Interested candidates please share the resume at manan.hathi@kashivindia.com
Ahmedabad
INR 19.0 - 25.0 Lacs P.A.
Work from Office
Full Time
Greetings from Kashiv Biosciences!!! We are looking for Process Equipment Engineer for our Biosimilar Manufacturing Plant Based out of Ahmedabad. Below are the further details. Experience 15 - 20 Years of Process Equipment Maintenance Education: B.E/ B. Tech( Mechanical/ Electrical/ Electronics/ Instrumentation) Roles & Responsibilities Responsible for the Plant Maintenance activity of DS (Drug Substance) section equipment's such as Fermenters, Process vessels, CIP vessels, batch centrifuges, TFF systems, Merck chromatography columns, Filter press . Responsible for the Plant Maintenance activity of DP (Drug Product) section equipment's Such as Vial Washing machine, Vial filling & Cap sealing machine, Laminar Air Flows, DPBs, Autoclave, Labelling machine etc. Responsible for Maintaining of biologics MFG units (Cell Culture), Filling Facility (DP),QC,WH and R&D facility . Maintenance of Biologics manufacturing facility (Mammalian) including Development and QC lab(Microbiology). Responsible for QMS Documentation validation and new Equipment Qualification. Required Instruments Exposure : Bioreactor Fermenter Media, Buffer & CIP vessel Continuous Centrifuge Continues Kill system Homogenizer Chrome system TFF system Autoclave Chromatography Candidate Details: The candidate should be from Biopharma industry having exposure Drug Substance and Drug product Maintenance. The candidate should have exposure to regulatory Audits. The candidate should be aware of GDP/ GMP Process. The candidate should have exposure to new equipment qualification & QMS as well . The candidate should have good communication skills. Interested candidate please share the resume on my mail id manan.hathi@kashivindia.com Regards HR Team Kashiv Biosciences
Ahmedabad
INR 5.0 - 8.0 Lacs P.A.
Work from Office
Full Time
Greetings from Kashiv Bioscience!!! We are looking for a Female enthusiast for our Supply chain Management Team based out of Ahmedabad. Roles and Responsibilities Core strength : The candidate should be well versed Strategic Sourcing Preferably Bio Pharma/ Biologics . the candidate should have good experience in Vendor development, Sourcing, Negotiation . Logistics Handling: The candidate should be aware of the basics of SCM Logistics . She should know how to Align Shipment movement. She should source best mode to movement & assign order to freight forwarder.. She should have knowledge of Import Clearance. She should have exposure to License reconciliation and Coordinating with Clearing Agents . She will be doing Documentation support . Basic Skills Expected : Hands on with MS Excel, Power Point. Awareness of ERP module and SAP Candidate Details We are looking for Female Candidates only for the role. The candidate should have good communication skills and negotiation skill. The candidate should have good MS Excel skills and exposure to ERP/ SAP. The candidate should be from Pharma/ Biologics/ Biotechnology company. Interested candidates please share the resumes at my mail id manan.hathi@kashivindia.com Regards Team HR Kashiv Biosciences
Ahmedabad
INR 15.0 - 20.0 Lacs P.A.
Work from Office
Full Time
Greetings from Kashiv Biosciences!!! We are looking for Utility(MEP) Engineer for our Biosimilar Manufacturing Plant Based out of Ahmedabad. Below are the further details. Experience 15 - 20 Years of Process Equipment Maintenance Education: B.E/ B. Tech( Mechanical/ Electrical/ Electronics/ Instrumentation) Roles and Responsibilities Drive and execute capex project from the inception to electro-mechanical completion and C&Q. Drive the project 100% independently and adhere project policy. Review the project plan and prepare list of deliverables require to complete the design. Float the enquiry to design consultancy firm for new projects. Review and participate in review of concept design layout. Review basic engineering and detailed design drawings of different package (i.e. HVAC, CU, HSE, Civil, Electrical, LVS and BU etc.). Review and prepared BOQ/BOM-related HVAC equipment and system. Prepare the MOM and share post-meeting as applicable. Support and provide support for routine operation and in HVAC, utility, and DS process maintenance. Prepare and propose budget with assumptions/basis for budget Raise CER against approved budget and ensure approvals as applicable. Track the approved capex budget to know the spent status. Prepare and propose budget amendment and seek approvals for additional budget. Prepare, review and get approved change control and other QMS element related to project. HVAC, clean utility, and black utility packages execute and qualify and get area released for routine operations. Well-versed in HVAC design, BMS, EMS, Water system. Well-versed in water systems like Pretreatment, purified water generation, and distribution, WFI generation, and distribution, and Pure steam generators. Compressed air, gas distribution system, IBR boiler, chiller, Chiller Plant Manager, cooling tower, kill tank system, and wet scrubber, etc. Candidate Details The candidate should be from Pharma industry only. The candidate should be aware of GDP/ GMP Process. The candidate should have exposure to equipment qualification, Validation and QMS . The candidate should have good communication skills. Interested candidate please share the resume on my mail id manan.hathi@kashivindia.com Regards HR Team Kashiv Biosciences
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