1. To prepare documents Technology Transfer Document, Product scale up report, Product development report, Chemistry manufacturing & control, Polymorphism study etc. 2. To collect necessary information from all concerned Department. 3. To prepare DMF (Drug Master File) for Regulatory Market. 4. To ensure that manufacturing procedure and specification of materials are in accordance with the submitted DMF.
Role & responsibilities : -Operation of pH meter, Conductivity meter, Karl Fischer, Halogen Moister analyser, Balance, UV- cabinet , Melting Point apparatus, UV spectrometer, Particle size analyser, Polari meter, Bulk Density, Sieve-Shaker, FT-IR, Potentiometer etc. -To perform analysis of in process, Intermediate, raw material, stability sample, holding time study sample & Finished products on HPLC & to maintain record accordingly. - To plan and perform analysis and reporting for column performance & to maintain vial destruction record.
Role & responsibilities : To prepare & review the MFC/BMR/BPR/ECR/BRPR/SRR/UCR/TCR for its compliance as per the requirement. To prepare & review protocol and report of the process validation, cleaning validation, blending validation & drying validation. To prepare & review SOP & other quality related documents.
Role & responsibilities -To perform the manufacturing process of products and to fill all the quality records in shift as per GMP. (BMR/BPR/ECR/Log Books/etc.) Following the SOP. -To give the requisition for Raw material/Packing material to Raw material store and verification of the same after receipt. -To give requisition for any consumable items to engineering store and verification of the same after receipt. -To give requisition for forms / formats and other quality related documents to QA and submission of the same to QA. -To make sure that all production deviations, non-conformance & accidents are reported along with investigation report. - To schedule training of plant personnel on SOPs, documentation and other cGMP compliances as per ICH Q7 and safety.
Role & responsibilities : 1) To plan analysis of in- process, intermediate, raw material, stability sample, holding time study sample & finished products on HPLC & check report of the same. (Dirty Equipment & Clean Equipment) 2) To distribute the shift wise work to analyst as per requirement in HPLC section & To plan calibration of HPLC /analytical balance as per schedule and review the same.
Role & responsibilities 1. To check & monitor administrative expenses like cleaning material. 2. To issue offer letter to the employees selected by the functional head up to position of executive. 3. To coordinating and review training needs/records of all the employees of the organization as per policy / SOP. 4. Responsible for induction of new employees into the organization up to executive position & ensuring all joining documents are collected. 5. Keep employees informed on the management policies. 6. To administer welfare schemes & ensure their implementation. 7. To take initiative & co-ordinate events, like celebration of festivals, get- together, sports, competition etc. 8. To ensure all the housekeeping & pest control are done as per the daily & monthly schedule. To check & verify the records also for the same. Preferred candidate profile Strong communication and organising skills. Fluent English. Responsibilities:
1. To prepare documents Technology Transfer Document, Product scale up report, Product development report, Chemistry manufacturing & control, Polymorphism study etc. 2. To collect necessary information from all concerned Department. 3. To prepare DMF (Drug Master File) for Regulatory Market. 4. To ensure that manufacturing procedure and specification of materials are in accordance with the submitted DMF.
Role & responsibilities 1. To review batch release documents for raw material/packing material /in process/intermediate /finished product/stability like test protocol / report, electronic data, chromatograms, audit trail, spectra, etc. 2. To execute audit trails and review the activity to verify the integrity of data. 3. To review electronic data back up and verification of restoration study, computer system validation, etc. 4. To review calibration/qualification/PM schedule/installation documents for instruments in Quality Control department. 5. To review analyst qualification and training related documents of quality control department. 6. To review documents related to working standard / reference standard / impurity standard / reference material / GC standard. 7. To review stability schedule and related analytical data. 8. To review holding time stability study data & related analytical data. 9. To review quality management system related activity for Quality Control (Change Control, Deviation, Quality Complaints, QRM). 10. To review investigation and ensure closure of laboratory incidents. 11. To review investigation and ensure closure of OOS/OOT/OOC in Quality Control department. 12. To review all the trends related to quality control activity 13. To review of documents related to microbiological activity like, environmental monitoring, water testing, finished product testing, validation-based testing, instrument calibration and validation activities, etc. 14. To take QC rounds and support in maintaining GLP, logbooks review, etc. 15. To review SOPs, specification and method of analysis, test reports / protocols / documents related to QC. 16. Review of analytical method transfer and analytical method validation documents.