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.
Ensure the on-time filing of high-quality regulatory submission, and to assist in the preparation, maintenance, and control of regulatory dossiers. Interact with Regulatory agency on regulatory submissions and follow up for drug product approvals.
Candidates having experience in monitoring and handling of shop-floor activities for Tablet, Capsule, Ointmnet, Ampoule, Vial and Injectable production operations, online documentation like log book & batch records and QMS