Otsuka Pharmaceuticals Ltd Released Job Openings On 06/06/2022. Otsuka Pharmaceutical India Private Limited is a Joint Venture between Otsuka Pharmaceutical Factory, Inc., Japan and Mitsui & Co. Ltd., Japan, India, for Infusion Business in India and Emerging Markets..
Vacancy Details:
Otsuka Pharmaceuticals Ltd Recruiting B.Sc,M.Sc,B.Pharm,M.Pharm Candidates with 2-7 years of Experience for CQA/QA(IPQA/Validation/QMS),QC-Chemical Analysis(RM/PM & IPPT/FP),QC-Micro Position.Complete Details for the CQA/QA(IPQA/Validation/QMS),QC-Chemical Analysis(RM/PM & IPPT/FP),QC-Micro as follows.
Important Details :
- Location : Ahmedabad( Moraiya )
- No of Vacancies:NA
- Details of Salary: NA
- Opening date for online Application: 06/06/2022
- Mode of application :Online
- Time And Venue : 11th June , 9.30 AM – 3.00 PM
Otsuka Pharmaceutical India Pvt Ltd 21st Floor, B-Block, Westgate, Nr. YMCA, S.G Highway, Ahmedabad – 380 015Contact –Â Team HRÂContact – The positions are for shift (rotational) operations and only for experienced candidates. Fresher candidates have to share their resume on hrm.opmf-amd@otsukapharma.in
Job Description/Skills Required
For CQA/QA(IPQA/Validation/QMS):-
- Execution of All IPQA related activities within manufacturing unit.
- Line clearance, in-process dispensing and sampling activities.
- BMR/BPR issuance, review and preparation under the guidance of seniors.
- Issuance of Standard Formats and submitting the documents.
- Preparation of SOP as per the current organization norms and cGMP guidelines under the observation of seniors.
- Execute routine IPQA monitoring.
- Review and approve on-line documentation of manufacturing, testing and packing activity.
- Investigation of any deviation / abnormal observation.
- Review the GDP issues in Production / QC / QA and in logbooks.
- Execute CAPA defined by management/QMS.
- Review critical quality attributes of products, review trend analysis and keep track of OOT results.
- Execution of All Process Validation related activities within manufacturing unit.
- Review process validation, qualification planner.
- Conduct Material issuance for validations activities.
- Sample withdrawal during process validation.
For QC-Chemical Analysis(RM/PM & IPPT/FP):-
- To carry out the sampling of all the materials according to Standard Operating Procedure (SOP).
- To carry out the testing of Raw Material and Packing Material according to approved procedure.
- To release Raw Material and Packing Material.
- To carry out the calibration of instruments as per the schedule.
- To prepare the working standards as per the guidelines and various pharmacopoeias.
- To ensure the status tag on the released material and transfer such material in the released area.
- To analyze the artworks as per the guidelines.
- To follow the Good Laboratory practices and Good Manufacturing practices (GMP).
- To prepare requirement list of chemical & reagent for procurement.
- To perform the analysis of stability sample as per current specification.
- To compile the data required for internal quality audit in the plant, as and when required.
- To implement the cGMP standards.
For QC-Micro:-
- To ensure the clean environment for sterile preparation by implementing the Good Manufacturing Practice (GMP) norms as per the international standards and guidelines.
- To do sampling of Water for Injection (WFI), Double Reverse Osmosis (DRO), Single Reverse Osmosis (SRO), Raw water and pure steam.
- To analyze water samples for pH, conductivity, Bacterial Endotoxin Test (BET), bioburden, Total Organic Carbon (TOC), pathogens, chlorides, hardness, silt density index and other testing as per the requirements.
- To analyze the samples of water system after maintenance work .
- To observe and record the results the microbiological plates and test tubes after analysis as well as supervise discarding method of same.
- To perform the timely microbiological testing of finished product samples, pre-sterile samples, Raw material as well as Packing material sample as per the requirements and SOPs and record the results for the same.
Click here for Official notification and ApplyÂ
