Alivira Animal Health is a USD 150mn integrated global animal health company operating in the area of animal health API and formulations with a strong presence across EU, Latin America, Turkey, Africa, India, and CIS, offering products across the feed, nutritional & therapeutic segments covering food-producing and companion animal species. Our vision is to be the best-in-class, integrated platform from APIs to Formulations in the hugely attractive global Animal Health market. Alvira is a subsidiary of Sequent Scientific Limited, a listed company operating in areas of Animal Health, Human Health, and Analytical Services, employing more than 1,600 people globally. (www.alivira.co)
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Designation: Sr Executive/Asst Manager – DQA (API)
Location: Visakhapatnam
Job Description:
- Job Responsibilities:
- Review of R&D technical package, development reports for APIs products
- Ensuring the design of experiments of new process under development in R&D scale
- Review of analytical spec and MOA right from the development phase to design and validation phase
- Design of in-process, intermediate, RM, and API Spec based on Process development study
- Review of Process validation bathes at lab scale and finalization of the process for piloting and plant scale batches
- Coordination with Site-QA /QC, R&D, ADL, Manufacturing, and process engineering team to deliver the documents and transfer of technology, knowledge from the R&D lab to commercial stage
- Issuance and control over the Development report, tech pack, R&D Spec, MOA, validation report, etc.
- Participation in Process development with R&D scientist to troubleshoot the process and offer a joint solution along with the R&D/PDL team.
- Responsible for Review and Approval of protocols and reports, SOPs and Master Documents pertaining to Research and Development activities and its compliance
- Responsible to coordinate with Vendor/SCM team for Review of Raw and Packaging Material vendor documents and their qualification requirements, Vendor information form, Process flow, Stability data requirement, GMP certificate, TSE/BSE, etc.
- Responsible to ensure compliance of R&D, ADL lab, conducting periodic audit and ensure on-line practices and documentation in R&D/PD Lab
- Should have Knowledge about APIs tech process, QBD Software, and DOE concept
Qualification: B.Sc, MS/M.Sc Chemistry
Experience: 6-10 Yrs in API Development R&D QA
Salary: 5,00,000 to 8,00,000 INR(CTC/PA)
Contact Details:
Swapnil Sarvankar
Eswara.V@alivira.in
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