5.0 - 9.0 years

0 Lacs

haryana

On-site

As a Senior Medical Editor at Syneos Health, you will play a crucial role in ensuring that all documents meet or exceed sponsor and regulatory requirements such as FDA, EU, and other relevant guidelines. You will represent the editorial group in Medical Writing, collaborate with study teams, and provide technical support and expertise as needed. Your responsibilities will include monitoring timelines and budgets for assigned projects, conducting training for medical editing staff, and serving as a project lead for complex medical writing projects. In this role, you will copyedit assigned documents following American Medical Association (AMA) or various custom style guidelines, perform data integrity reviews to ensure accuracy, and contribute to the development of process improvement tools. Strong attention to detail, excellent grammatical and communication skills, and proficiency in Microsoft Office Suite are essential for success in this position. Additionally, you should have a Bachelor's degree in the life sciences, clinical sciences, or English/journalism, along with at least 5+ years of medical editing experience. As part of the global Medical Writing team, you will collaborate with passionate problem solvers to accelerate the delivery of therapies and make a meaningful impact on changing lives. Syneos Health is committed to developing its people through career progression, supportive line management, and a Total Self culture that values authenticity and diversity. Join us in creating a place where everyone feels like they belong and where your work truly matters everywhere. If you have a strong background in copyediting, data integrity review, and relevant publishing experience, along with a passion for making a difference in the healthcare industry, we invite you to explore this exciting opportunity at Syneos Health.,

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Junior QA Executive - Male Shree Ganesh Remedies

1.0 - 2.0 years

3 - 3 Lacs

Dahej, Vapi, Kamrej

Work from Office

. Execute and monitor day-to-day manufacturing activities as per BMR/BPR. . Operate, monitor, and clean production equipment (reactors, centrifuges, dryers, etc.). . Follow batch processing as per defined SOPs and production schedules.

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Process Head KAVS SPECTRONOVA TECHNOLOGIES PRIVATE LIMITED

8.0 - 12.0 years

0 Lacs

thane, maharashtra

On-site

As a Process Head at Kavs Spectronova Technologies Pvt Ltd, you will be responsible for leading the process engineering aspects of pharmaceutical plant projects. Your role will involve overseeing optimal process design, ensuring regulatory compliance, and facilitating seamless coordination among internal and external stakeholders for both greenfield and brownfield facility projects within the pharmaceutical industry. Your key responsibilities will include leading the end-to-end process design for various types of pharmaceutical facilities such as OSD, Injectable, Vaccine, or Biotech. You will be required to develop and review essential documents including P&ID, Process Flow Diagrams, Mass Balances, Equipment Sizing, and Critical Design Parameters. Additionally, you will prepare and evaluate User Requirement Specifications (URS) and oversee various tests and validation protocols such as FAT, SAT, DQ, IQ, OQ, and PQ to ensure compliance with regulatory standards like GMP, WHO, USFDA, and EU. Collaboration with cross-functional teams such as R&D, Quality Assurance, HVAC, Utility, Electrical, Instrumentation, and Automation will be a crucial part of your role. Your technical expertise and leadership will be essential during project execution, commissioning, and regulatory audits. Client meetings, technical presentations, and troubleshooting activities will also be a part of your regular responsibilities, along with international travel for projects, site visits, audits, and technical review meetings. To qualify for this position, you should hold a Bachelor's or Master's degree in Chemical Engineering or Pharmaceutical Engineering with 8 to 12 years of experience in process design and execution of pharmaceutical plant projects. A deep understanding of regulatory requirements including GMP, WHO, USFDA, and EU is essential. Demonstrated leadership skills in managing diverse teams and external consultants/vendors, excellent communication, documentation, and presentation abilities, as well as the capability to handle multiple projects under strict timelines are required. A valid passport is mandatory for this role, and prior international exposure is highly desirable. In return, we offer you a challenging leadership role in global pharmaceutical projects, opportunities for international exposure and career advancement, a collaborative work environment that emphasizes innovation and compliance, as well as competitive compensation and benefits in line with industry standards. To apply for this position, please send your updated resume to suchita@spectronova.com with the subject line: Application for Process Head Pharma Projects.,

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