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Job Location | Kolkata |
Education | Not Mentioned |
Salary | Not Disclosed |
Industry | Pharma / Biotech |
Functional Area | Hospital Management / DirectorMedical Transcription |
EmploymentType | Full-time |
Job SummaryAs the only fully, Vertically Integrated manufacturer of Steroid-Hormone APIs in India, we offer the unique proposition of providing Steroid-Hormone API Solutions with regulatory support matching Western Standards with Asian Cost Advantage.The company has successfully completed the construction of its II phase of expansion in i.e. Fermentation Facility and construction of it Chemical Synthesis Facility and production is started.Chemical Synthesis Facility at Special Economic Zone (SEZ), Pithampur is made to start backward integration of some of its important raw materials like Hydrocortisone Acetate and Betamethasone Base which can be used as intermediate product as well can be sold in the market.The facility at SEZ , Pithampur is an ultra-modern cGMP compliant Steroids plants with production facilities ranging from a kilo scale to several ton capacity with single batch size exceeding 500 kg for several APIs with dedicated R&D and well equipped Quality Control Laboratory.Responsibilities and Duties1.API Production:Position- Chemist/ Officer/ Sr. Officer/ExecutiveExperience- 2-8 YearsQualification- B.Sc/ M.Sc/B.E./ B.Tech1. To perform and control the manufacturing activities in shift.2. To maintain batch manufacturing records for the batch manufactured and check that all the BMRs are adequately filled.3. To maintain all related documents for production.4. To co-ordinate with engineering and maintenance department for routine activities.5. To co-ordinate for the raw materials from stores.6. To perform in safe work environment.7. To allocate manpower for shift activities.8. To monitor and maintain good housekeeping in respective areas.9. To perform and achieve department objectives.2.Quality Control:Designation- Chemist/ Officer/ Sr. OfficerQual- Bsc/ Bpharm/ Msc/ MpharmExperience- 1-5 YearsInstruments Handled- GCJob Responsibility :1. To maintain calibration records of Gas chromatography in QC lab.2. To perform GC calibration and maintain record.3. To initiate and completion of analytical record for Gas chromatography.4. To carry out the GC analysis of raw materials, finish products and intermediates as required.5. To perform and achieve departmental objectives.6. To follow the guidelines of GLP and cGMP requirements.7. To carry out instrumental analysis of stability samples.8. To maintain GC columns records3.Inoculum (Biotech):Designation- Jr. ExecutiveExperience- 1-5 YearsQual- M.sc (Micro/ Biotechnology)Job Responsibility:1. To follow the SOPs of Inoculum lab and maintain the training record.2. To monitor the lab equipments and record their status.3. To perform verification and calibration of lab instruments.4. To prepare the batch media and fill the batch manufacturing record.5. To prepare culture media and sterility media.6. To perform the sterility test.7. To perform and record isolation and propagation and maintenance of microbial culture8. To perform the productivity test.9. To follow the production planning.10. To coordinate with QA department for issuance and submission of lab records and for calibration and validation of lab equipments.11. To coordinate with QC and Micro department for analysis, microbial monitoring and GPT of media.12. To coordinate with ware house department for issuance of batch media.13. To coordinate with maintenance department for calibration and validation of lab equipments.14. To follow the GMP and GDP procedures in Inoculum lab.4.R & D:Designation-Jr. Executive/ExecutiveQual- MSCExperience- 1-5 Years1. To follow the SOPs of R&D lab and maintain the training record2. To monitor the lab equipments and record their status3. To follow the SOPs in the lab respectively4. To execute the R&D experiments given by senior5. To prepare and control the SOPs and STPs6. To perform the sterility test and maintain its record7. To perform daily routine sample analysis8. To review and update monthly records9. To assign the work of helpers and workers10. To train the junior staff and workers11. To coordinate with suppliers for R&D instruments regarding maintenance12. To perform the calibration of instruments like pH meter, weighing balance, HPLC, UPLC, etc.13. To coordinate with QA department for issuance and submission of lab records and for calibration and validation of lab instruments14. To follow the GMP and GDP procedures in R&D lab5. IPQADesignation-Chemist/ OfficerQual- Bsc/ Bpharm/ Msc/ MpharmExperience- 1-5 YearsJob Responsibility:1. To issue correct version of BMR/BPR/PCOCR/MCVR and other documents.2. To review filled Batch manufacturing record and analytical record.3. To prepare the department SOP as and when required.4. To maintain the records for FP/Intermediate batch release documents.5. To prepare and review of the APQR.
Keyskills :
rofessional liability change control continuous improvement facilitation process validation entertainment writing quality control maintenance department data control cleaning validation production facilities chemical synthesis internal audit