Indivirtus Healthcare
Indivirtus Healthcare, a fastest growing CRO, is the parent company of Indivirtus Group.
In active operations of just 6 years, Indivirtus has
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become is a group of 5 companies
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served 553+ clients in 51 countries across 6 continents
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established 5 international business offices
Indivirtus Healthcare offers following specialized services to pharmaceutical companies:
- Green Field/ Brown field projects
- Computer System Validation
- Equipment Calibration (NABL approved lab)
- Formulation Development & Analytical Method Development/ Validation and Tech Transfer
- Gap assessment Audits for regulatory approvals of plant and Trainings
- Vendor Audits
- Toxicological Studies i.e. PDE/ADE | OEL | Genotox Assessment of Impurities
- Regulatory Affairs- Dossiers, DMF and MSDS preparation as well as Medical device registration
- Pharmacovigilance
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Clinical Trials and BA/BE studies
Interested candidates may share CV at hr@indivirtus.com with CC to admin1@indivirtus.com
Shortlisted candidates will be informed by HR team about further process of interview.
Mohali/Chandigarh (Only the candidates, who are willing to relocate to Mohali/Chandigarh should apply) | |||||
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Department | Designation | No. of Positions | Job Description | Relevant Experience | Offered CTC Range |
Technology Transfer | Associate Executive-Tech Transfer | 2 | Develop and execute plans for transferring pharmaceutical technologies (formulations, processes, equipment) between R&D, manufacturing sites, or between different companies. | 3-5 years of relevant exp | 20-25% rise on current CTC |
Identification of risks during technology transfer and implement mitigation strategies to address them | |||||
Create, review and maintain detailed documentation including product development report, master batch records, process flow diagrams. | |||||
Knowledge of Design and development of tablet formulations, including pre-formulation studies, selection of excipients, Identification of CQA, CMA & QTPP. Formulation optimization and process optimization. | |||||
Coordinate with multiple teams, including manufacturing, quality assurance and regulatory affairs to ensure smooth technology transfer. | |||||
Participate in regulatory submissions and ensure all documentation aligns with the requirements of regulatory bodies. | |||||
Assist in optimizing processes during technology transfer to ensure scalability and efficiency in manufacturing process. | |||||
Troubleshoot any issues related to the scaling of processes or technology, providing support for troubleshooting and resolving any technical difficulties. | |||||
Analytical Department | Associate Analyst | 1 | Performing the AMV activities for Tech Transfer | 3-5 years of relevant exp | 20-25% rise on current CTC |
(1) The person should be well experienced in Analytical method validation and analytical method transfer for Assay, Dissolution and Related substances. | |||||
(2) Should be able to do troubleshooting during method validation and method transfer activities. | |||||
Associate Analyst | 1 | Qualitative and Quantitative estimation of degradation, nitrosamine and extractable & leachable impurities | 3-5 years of relevant exp | 20-25% rise on current CTC | |
Regulatory Affairs | Associate-Regulatory Affairs | 4 | Preparation of CTD and eCTD dossiers/DMF | 3-5 years of relevant exp | 20-25% rise on current CTC |
Preparation of documents related to technology transfer i.e. BMR, PDR etc. | |||||
Bioanalytical | Bioanalyst | 2 | Develop and validate analytical methods for drug molecules in biological matrices; analyze study samples for bioequivalence | 3-5 years of relevant exp | 20-25% rise on current CTC |
Operate LC-MS/MS and other relevant equipment for bioequivalence studies. | |||||
Prepare batches, load and analyze samples, check results for acceptance, and identify repeat/reinjection needs. | |||||
Have good knowledge and ensure compliance with applicable regulatory guidelines and practices. | |||||
Pharmacovigilance | Sr. PV Associate | 1 | The Senior Drug Safety Associate will provide technical and process-related support to drug safety management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs). | 3-5 years of relevant exp | 20-25% rise on current CTC |
Responsible for processing of Individual Case Safety Reports (ICSRs) from various sources, Literature search and review, signal detection and management, tracking regulatory information, performing regulatory submissions and supporting preparation of aggregate and other study reports, as well as Medical and Product Dictionary Management activities, where applicable | |||||
Responsible for ICSR compliance and related processes including but not limited to quality review of ICSRs, metrics generation and late case investigation in accordance with International and local regulatory reporting requirements, where applicable | |||||
Calibration | Calibration Engineer | 1 | B. Tech or Diploma in Mechanical Engineering Calibration of Electro Technical, Thermal and Mechanical | 3-5 years of relevant exp | 20-25% rise on current CTC |
Business Development | executive- Business Development | 2 | Fresh B Pharm graduates | Freshers | 2.4 Lacs/annum |