Interpret and compile external supplier APQR and or extracted data from Internal Sandoz systems into a pre-defined template and draft conclusion of product quality review.
To search on various country patent databases to retrieve equivalent patent information, legal status etc., in different geographies. To prepare patent landscapes, analyze the patent content to summarize their claims and specification.
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.
Preparation and review of test procedure, development reports, method validation protocol and LNBs. Perform calibration of the analytical instruments as per calibration schedule. Analytical method development, validation, and sample analysis for Extractables and Leachables using HPLC, LCMS, GCMS and ICPMS. Identification and characterization of unknown impurities by LCMS.
Capture critical unit operation parameters and ensure accurate representation in business process flow mappings. Facilitate workshops and discussions to align stakeholders on current workflows and identify gaps or improvement areas. Data Analysis and Technical Insights.
B.Sc. / B.Pharm/ M.Sc.; Hands-on experience in Analytical Method Validation, Method Transfer, Protocol Review, Analysis of CU, BU, Assay on HPLC & UV Spectrophotometer, BD, TD, PSD & Water Content, Tests are performed daily to daily on job.
B.Sc./ B.pharmacy graduate with MBA or equivalent qualification. Proven track record of leading a large, geographically diverse sales team, including at least 2 years of experience overseeing half of India with consistent performance, growth and positive P&L outcome.
Must know process validation cleaning validation verification and hold time studies. Candidate should also have exposure to EU, MHRA, and USFDA regulatory audits.
Plan and coordinate with various departments like QA, QC and Production, to project the document requirements for appropriate submissions. Co-ordination with clients for the tracking and status update of project plans.
Candidates having hands-on experience in Analysis of Raw Material, Packaging Material, Finished Goods, Stability, Method Transfer and Laboratory Investigations. Should have sound knowledge of QMS like Deviations, Change Control, Vendor Management etc.