Executive, Indore

Job Description To support Lab (Analytical) for maintaining Quality and compliance as per the GMP norms Position / Job Title - Executive Department - Quality Assurance– Analytical Lab Quality Assurance Reporting To - Senior General Manager – Quality Assurance Location - PithampurYears of Experience - 6 Years Dosage Form - Solid Oral / Cream and Ointment experience is must Job Responsibilities / Deliverables - Well versed in the analytical review of documents, which includes those from GLP section. Handling of OOS, OOT, Events, Change control and CAPA. Review and ensure compliance of Column management, Standard management, glassware management and chemical management.Responsible for Retention samples management and review of stability sample and stability study management. To review of stability protocol/summary sheet Review Computer system validation, calibration&qualification of instruments. Review of audit trails from the computerized systems. Ensure QC laboratory compliance at all times, participate in Lab check rounds. Preparation&review of OOS/OOT/Events trending. Review of analytical documents, chromatograms related to AMT/AMV protocols and reports. Preparation of SOPs To review the Analytical reports in support of Batch release activities To review and approve the batches with generation of Certificate of Analysis for Finished ProductReview Analyst qualification data Qualifications&Pre-Requisites Should be Graduate/Post graduate in Science or Pharmacy Must have knowledge on handling HPLC, GC, KF, Dissolution. FTIR, FTNIR is preferable. Exposure to various regulatory bodies like US FDA, MHRA, TGA Exposure to specific dosage forms like OSD (preferred) Expertise in Qualification of CSV instrument documents verificationExpertise in Method validation and Analytical method transfer process Exposure to expertise towards handling of QMS records Additional Notes Role is expected to work in all shifts. Expected to visit Satara/Thane sites at least twice a month on need basis.