Please find the below details for position - Validations-AR&D-API. Kindly revert to mail.
- Analytical method validation of API, Intermediates and Raw materials by HPLC.
- Analytical method development and regular analysis.
- Analytical method transfer of finished product, Intermediates and KSMs .
- IR and UV analysis.
- Wet analysis.
- Good exposure on Empower-3 software with custom fields.
- Calibration of HPLC.
- Well versed with ICH, OECD GLP and regulatory guidelines for analytical method development and
- their validation.
- Calibration of Analytical Instruments, Equipments like HPLC calibration.
- Successful Completion of Projects by proper planning, effective time management and team
- Maintenance of Reference Standards & Working Standards as per Validity.
- Maintenance of Laboratory Documentation. Good at documentation as per GLP.
Role:Research & Development - Other
Salary: Not Disclosed by Recruiter
Industry:Pharmaceutical & Life Sciences
Functional Area:Research & Development
Role Category:Research & Development - Other
Employment Type:Full Time, Permanent
PG:MS/M.Sc(Science) in Any Specialization,M.Pharma in Any Specialization
Biophore India Pharmaceuticals Pvt. Ltd.
Biophore is a research driven global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs) having its operations based in Hyderabad, India and also has a registered office in New Jersey, USA. Biophore has two dedicated R&D facilities in Hyderabad and Vishakapatnam. The research facilities are fully equipped with wide range of R&D and process equipment from USA with reaction capabilities from milligram to kilogram. Ever since its establishment in 2007, Biophore recognized that there were two ways of growing the API business: manufacture a large API product basket, or pick a handful of promising APIs in select therapeutic categories and grow them over the long-term. Biophore consciously chose the latter option and focused on not only building competencies and adding scale in those segments but more importantly, building efficiencies that would make it an undisputed leader in these products of choice. The product range is constantly expanded through its own R&D, process development, technology transfers, joint ventures and collaborations. Biophores core strength lies in development of non – infringing routes for comprehensive range of bulk actives and intermediates, development of niche APIs, oncology APIs, APIs for MRI contrast agents and APIs for NCE - 1 filing. Biophore has made strategic investments in two manufacturing facilities. Sionc pharmaceuticals & Azico – Biophore, Both located at Vishakapatnam. Among them Sionc, a multi-purpose plant has passed FDA inspection in 2013 & 2016 with no observations on the Form 483. This is the reason to be proud and confirmation of the highest quality standards of Biophore. Our other facility Azico – Biophore is also a n FDA approved facility that strictly complies with cGMP procedures and maintains well documented SOPs, with a modern quality control laboratory thereby ensuring the production of highest quality APIs.