Intas Pharmaceuticals Ltd, Experience spanning three decades in healthcare, with a wide range of formulations to meet the needs of ailing humanity, Intas Pharmaceuticals headquartered at Ahmedabad (India), is now a force to reckon with, in the global pharma horizon. With expertise in a range of formulations, from tablets to injectables to newer drug delivery systems, Intas is currently ranked 17th among the Indian Pharma majors. A variety of initiatives in Research and Development, patents and ANDA filing, NDDS, quality manufacturing support, along with approvals by regulatory authorities of many countries has made Intas a global healthcare provider. Pioneering efforts in providing medications for both chronic and acute medical conditions, has truly led Intas live up to its corporate line Expressions for a Healthy Life.
Job Description
Roles and Responsibilities
1. Analytical QA / Lab QA (QA to QC)
Having Experience in QC instrument knowledge, chromatographic practices, LIMS software, and other standalone instrument software experience.
2. Data Integrity (Formulation & API)
All possible Data Integrity, EBMR, Documents, Logbooks, Handling of paper, Audit Trail vs actual execution at site.
3. Quality Assurance IPQA Validation & Qualification (Injectable)
Process and Cleaning validation, validation documents, protocol report, and risk assessment
Equipment qualication documents (URS, FAT, SAT, DQ, IQ, OQ, PQ) & Compliance mgt.
SME in HVAC validation, temperature distribution study, and Equipment Qualication
4. 21CFR Part 11 Compliance (Formulation & API)
Tracking of documents for the dossier, queries response, Harmonized document for single ANDA / Dossier; regulatory commitments.
5. General Parenteral
SVP manufacturing / Asceptic / Filling / Washing / Autoclave.
6. Oncology Parenteral
Manufacturing of SVP, Filling & Lyophilization, Media Fill, Qualification, Vial Washing & Depyrogenation, Visual Inspection and handling of QMS activity
Desired Candidate Profile
Having good regulatory audit exposure.
Minimum 3 years of experience is required.
Similar Jobs: Chemveda Life Sciences- Walk-in Drive For Multiple positions on 25th Feb 2023
More Job Updates Join What’s App Group – Click Here
Join Telegram Group – Click Here