Oversees the development, implementation, and maintenance of the Quality Management System within the Probiotics or Non-Aseptic manufacturing facility. This includes ensuring that all processes, procedures, and documentation comply with relevant regulatory standards such as Good Manufacturing Practices.
Granules India is a vertically integrated, high-growth pharmaceutical company with 38 years of proven performance and increasing performance and increasing presence across the world. Headquartered in Hyderabad, India, Granules offers collaborative and strategic partnership to global pharmaceutical leaders by producing best quality API, PFI and FD through manufacturing excellence, process innovation and regulatory expertise.
Regulatory Submissions Prepare, submit, and manage regulatory filings for API products, including new drug applications, amendments, and variations, while ensuring compliance with relevant guidelines and regulations. API Equipment Handling.
Pre formulation studies of Pharmaceutical & Medicinal Devices and to check the compatibility of the API with different excipients. Formulation development of Pharmaceutical & Medicinal Devices. Execution of successful technology transfer at commercial site.
This is a hands-on, non-supervisory, non-laboratory role in the India Biologics department. The incumbent will support the reference standard program within the Global Biologics department. The incumbent in this role will focus on supporting the suitability program, including preparing and reviewing CSU testing protocols, providing technical assistance to testing labs, reviewing analytical data and preparing summary reports to assist in confirming the continued suitability of USP Reference Standards.
The Qualification Expert for Analytical Instrumentation is responsible for ensuring the accuracy and reliability of analytical instrumentation used in various scientific processes. They will be responsible for assessing and verifying the qualifications of these instruments, as well as documenting and maintaining the records.
Aculife Healthcare Pvt. Ltd Company is a part of $4 billion Nirma Group & it is one of world's largest Infusion & Injectable Company, having a State-of-the art manufacturing facility spread over 550 acres of land located near Ahmedabad, Gujarat. Aculife healthcare has global operation in more than 100 countries and it has subsidiaries in Brazil, Mexico & Vietnam. The manufacturing facility has 2 plants with FFS technology, 1 Glass injectable plant and a one dedicated R&D center equipped with advance technology and unmatched research team.
Sun Pharma is the fourth largest specialty generic pharmaceutical company in the world. We provide high- quality, affordable medicines trusted by healthcare professionals and patients in over 150 countries.