Assistant Manager, Technical Writing
पद का विवरण
Essential Functions:
- Manage and coordinate technical writing activities for manufacturing SOPs, batch records, work instructions, and other GMP-critical documents
- Implement and manage electronic document management systems to improve document accessibility and control efficiency
- Translate complex manufacturing processes and technical information into clear, accurate, and compliant technical documentation
- Review and revise existing technical documents to ensure accuracy, completeness, and alignment with current regulatory requirements and manufacturing practices
- Develop and implement documentation schedules and workflows to ensure timely creation and revision of technical documents across manufacturing areas
- Ensure all technical documents comply with applicable regulatory requirements including FDA, EMA, and other relevant authorities
- Collaborate with manufacturing, quality assurance, and regulatory affairs teams to ensure technical documents accurately reflect processes and regulatory expectations
- Identify documentation gaps and initiate corrective actions to address them in a timely manner
- Train manufacturing personnel on technical writing standards and GMP documentation best practices
- Lead participation in process improvement projects to develop methods and procedures that enhance documentation quality and standardize technical writing practices.
Education:
- B. Pharm B. Pharm - Required
- M. Pharm M. Pharm - Preferred
Experience:
- 8 years or more in 8 - 10 Years
Specialized Knowledge: Licenses:
उल्लिखित कौशल
At Amneal Pharmaceuticals, we are at the forefront of revolutionizing the pharmaceutical industry through a relentless focus on innovation and accessibility. Our journey began in 2002 with a vision to make essential medicines more attainable, and today, we are a global biopharmaceutical powerhouse. Through groundbreaking technology and a commitment to scientific rigor, we are fundamentally reshaping how generic and specialty pharmaceuticals are developed, manufactured, and distributed. Our diverse and expanding portfolio of over 280 products is a testament to our dedication to addressing a wide spectrum of healthcare needs. We are not merely a generics company; we are pioneers in creating complex formulations, including injectables, biosimilars, and advanced drug delivery systems that challenge the status quo and provide new therapeutic options for patients. Our innovation extends beyond our product pipeline. We have made substantial investments in state-of-the-art research and development facilities, both in the United States and India, fostering a culture of continuous improvement and scientific excellence. This global footprint allows us to leverage diverse talent and cutting-edge technologies to accelerate the development of high-quality, affordable medicines. We are particularly focused on advancing treatments for central nervous system disorders and endocrine diseases through our Specialty division, bringing novel branded pharmaceuticals to market. At Amneal, we believe that a healthier future is possible for everyone. By challenging conventional thinking, investing in transformative technologies, and fostering a passionate team dedicated to our mission, we are not just manufacturing medicines; we are engineering solutions that improve and save lives across the globe, ensuring that high-quality healthcare is not a privilege, but a right.
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