Home / Job / Walk-in Interview for QA(IPQA/Validation/QMS), QC-Chemical Analysis(RM/PM & IPPT/FP), [email protected] Otsuka Pharmaceutical, Ahmedabad on 18th Dec. 21

Walk-in Interview for QA(IPQA/Validation/QMS), QC-Chemical Analysis(RM/PM & IPPT/FP), [email protected] Otsuka Pharmaceutical, Ahmedabad on 18th Dec. 21

Walk-in Interview for QA(IPQA/Validation/QMS), QC-Chemical Analysis(RM/PM & IPPT/FP), [email protected] Otsuka Pharmaceutical, Ahmedabad on 18th Dec. 21

Walk-in Interview for QA(IPQA/Validation/QMS), QC-Chemical Analysis(RM/PM & IPPT/FP), QC-Micro@ Otsuka Pharmaceutical, Ahmedabad on 18th Dec. 21

 

Job description

For 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.

  • 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.

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.

  • Note: The above positions are for shift (rotational) operations and only for experienced candidates. Fresher candidates have to share their resume on [email protected]

    Time and Venue :

    18th December , 9.30 AM – 3.00 PM

    Otsuka Pharmaceutical India Pvt Ltd 21st Floor, B-Block, Westgate, Nr. YMCA, S.G Highway, Ahmedabad – 380 015

    Contact – Team HR

     

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