Otsuka Pharmaceuticals Ltd - Urgent Openings in QC / QA / Production / ADL Departments
Opening For Officer- QC @ Otsuka Pharma, Ahmedabad (Japanese MNC)
Experience: 2-6 yrs
Qualification: B.Pharm / M.Pharm / B.Sc / M.Sc (Chemistry, Biotech, Microbiology)
Job description:
To carry out the sampling of all the materials according to Procedure
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 reagent & volumetric solution and standardize it.
To carry out all the necessary tests and record the results for all the material.
To record all the data related to the testing online, on day-to-day basis and ensure easy traceability.
To prepare requirement list of chemical & reagent for procurement.
To perform the tests as per the specification & method of analysis and record the necessary results in prescribed documents.
To investigate failure of finished product (FP) / In-process (IP) product, in case of any out of specification (OOS) / deviation and take corrective and preventive actions.
To carry out the calibration of all the analysis instruments as per the schedule.
We are looking for qualified and experienced candidates for our Quality operations. Candidates possessing good communication skill and exposure in Parental formulations.
Opening For Officer- QA @ Otsuka Pharmaceutical, Ahmedabad
Experience: 2-6 yrs
Qualification: B.Pharm / M.Pharm / B.Sc / M.Sc (Chemistry, Biotech, Microbiology)
Job description
- To verify raw material, primary packing material at the time of material issuance and material dispensing.
- To perform routine IPQA monitoring like volume check, critical control step verification during manufacturing of the product, sampling and periodic verification activities.
- To verify sample / good destruction process .
- Receipt and handling of data loggers.
- To carry out reconciliation and physical verification of the returned goods.
- To verify logbooks, online documents, records, analysis report and other supporting documents related to products manufactured in the plant.
- To execute the Corrective and Preventive Action (CAPA) defined by Quality Management System (QMS),
- To verify secondary packing material.
- To execute line clearance for routine packing activity, monitor each packing line at regular time interval and sample collection.
- To support in trend analysis of the packing line monitoring and keep track of Out of Trend (OOT) .
- To execute the CAPA defined by QMS .
Opening For Officer/ Sr. Officer- Production@ Otsuka Pharma, Ahmedabad
Experience: 2-7 yrs
Qualification: B.Pharm / M.Pharm / B.Sc / M.Sc (Chemistry, Biotech, Microbiology)
Job description
- To ensure the cleanliness and environmental norms of various area like dispensing, compounding, filling, capping, including airlocks .
- To ensure cleaning and disinfection of floor, ceiling, wall and equipments.
- To ensure that the maintenance of dispensing compounding, filling, capping, including airlocks is as per Standard Operating Procedure (SOP) norms.
- To carry out planning of material issue and dispensing as per priority of batch manufacturing.
- To prepare documents regarding material issue and dispensing.
- To issue the material from store as per Batch Manufacturing Record.
- To ensure the batch manufacturing process is done as per Batch Manufacturing record.
- To control the timing of Cleaning In Process (CIP) / Sterile In Process (SIP) and batch manufacturing process, to start the production timely.
- To do the Bubble Point Test (BPT) / Forward Flow Test (FFT) of product filter before and after filtration and Water Intrusion Test (WIT) of air filters.
We are looking for qualified and experienced candidates for our Manufacturing operations. Candidates possessing good communication skill and exposure in Parental formulations
Looking For ADL Officer _ Otsuka Pharmaceutical, Ahmedabad
Experience: 2-6 yrs
Qualification: B.Pharm / M.Pharm / M.Sc
Job description
- Responsible for Analytical Method Validation and Method Development activity.
- To perform F&D sample analysis.
- Responsible for Good Lab Practices (GLP) Activities and its complies.
- Responsible for Calibration of lab instruments.
- Preparation and review of Validation Protocols/Reports and Analytical Reports including data.
- Preparation/Review of SOP and its compliance.
- Responsible for Procurement of analytical and Lab requirements.
- To maintain the Documents of Analytical Protocols and Reports including Validation and Development.
- Responsible for maintain the stock of Laboratory requirements including chemicals and other analytical requirements.
- To maintain all data and log book records with Online as per GLP Requirement
E-Mail: hrm.opmf-amd@otsukapharma.in / sagar.somaiya@otsukapharma.in
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