Walk-in on 10th June for QA/QC/IPQA/QMS | Otsuka Pharma | Ahmedabad

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Job Overview

  • Date Posted
    June 7, 2023
  • Location (State / UT)
  • Expiration date
    April 17, 2024
  • Experience
    2 Years, 7 Years
  • Gender
  • Desired Qualification
    Bachelor Degree, Master’s Degree

Job Description

Walk-in on 10th June for QA/QC/IPQA/QMS

For QA/CQA(IPQA/Validation/QMS):

  • Execution of All IPQA-related activities within the 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 online 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 the manufacturing unit.
  • Review process validation, and qualification planner.
  • Conduct Material issuance for validation activities.
  • Sample withdrawal during process validation.
  • Record observations in observation sheets for process validation.
  • Coordinate and execute process validation, and qualification activities & inform about deviations from planning.
  • New equipment qualification & validation.
  • To help in the identification of any deviation and report further.
  • To support in the investigation of any product deviation and Out of Specification (OOS).
  • To suggest/recommend the changes in the Standard Operating Procedure (SOP).
  • To help in the 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 reports 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 Materials and Packing Materials according to the 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 pharmacopeias.
  • 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 a requirement list of chemicals & reagents for procurement.
  • To perform the analysis of the 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 a clean environment for sterile preparation by implementing the Good Manufacturing Practice (GMP) norms as per the international standards and guidelines.
  • To do a 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 another testing as per the requirements.
  • To analyze the samples of the water system after maintenance work.
  • To observe and record the results of the microbiological plates and test tubes after analysis as well as supervise the discarding method of the same.
  • To perform the timely microbiological testing of finished product samples, pre-sterile samples, Raw material as well as Packing material samples as per the requirements and SOPs and record the results for the same.

Candidate Profile:

  • Ready to work in rotational shifts.
  • Excellent understanding of the 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.
Note: The above positions are for shift (rotational) operations and only for experienced candidates. Fresher candidates have to share their resumes through Apply Now Option

Qualification: B.Sc./M.Sc./B.Pharm./M.Pharm

Walk-in Details

Date & Time: 10th June , 9.30 AM – 3.00 PM


Otsuka Pharmaceutical India Pvt Ltd

21st Floor, B-Block, Westgate, Nr. YMCA,

S.G Highway,

Ahmedabad – 380 015