Otsuka Pharmaceutical India Private Limited (OPI) is a Joint Venture between Otsuka Pharmaceutical Factory, Inc., Japan and Mitsui and Co. Ltd., Japan, India, for Infusion Business in India and Emerging Markets.
Post : QA(IPQA/Validation/QMS/Doc Cell)/QC-Chemical Analysis/ADL
Qualification : B.sc,M.sc,B.pharma,M.pharma
Experience : 2 to 7 years
Job Description
For QA (IPQA/Validation/QMS/Doc Cell)
• 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.
• Record observations in observation sheets for process validation.
• Coordinate and execute process validation, qualification activities & inform about deviation from planning.
• New equipment qualification & validation.
• To help in identification of any deviation and report further.
• To support in investigation of any product deviation and Out of Specification (OOS).
• To suggest / recommend the changes in the Standard Operating Procedure (SOP).
• To help in investigation of OOS and Documentation of the same.
• To be updated about the new changes in all international and local regulatory requirements.
• To monitor and implement the Good Manufacturing Practice (GMP) standards in the plant.
• To help in conducting monthly Corrective and Preventive Action (CAPA) meetings and preparation of CAPA summary report and gather CAPA details generated from individual quality sub-systems (e.g. Deviation, Change Control, OOS, Complaint, External inspection, Self-inspection).
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.
For ADL
• 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.
Candidate Profile
• Ready to work in rotational shifts.
• Excellent understanding about working area.
• Initiator and Learner.
• Decision making ability.
• Team player and if required, can provide training to other team members.
• Good communication.
• Exposure in Parenteral Formulation.
Job Location : Ahmedabad( Moraiya )
Interested and eligible candidates can attend interview on scheduled time and venue
Walk in Interview
Date : 23 October 2021
Time : 09:30 am - 03:00 pm
Venue : Otsuka Pharmaceutical India Pvt Ltd.
21st Floor, B-Block, Westgate, Near YMCA Club, S.G.Highway. Ahmedabad-380015
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