Manager – QA (IPQA) | Hetero Drugs | Jadcherla | 10.00-17.00 L

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Job Overview

  • Date Posted
    24/09/2022
  • Location (State / UT)
  • Expiration date
    --
  • Experience
    9 Years, 12 Years
  • Gender
    Any
  • Desired Qualification
    Bachelor Degree
  • Salary in (₹)
    10,00,000 - 17,00,000

Job Description

  • Responsible for monitoring compliance with the requirements of GMP.
  • Responsible for review and approval of Validation and Qualification Protocol and reports and participation in the validation of Programmers.
  • Responsible for review and approval of Batch Manufacturing and Batch Packing Records.
  • Responsible for evaluation of in-process controls.
  • Inspection, investigation, and taking of samples in order to monitor factors that may affect product quality.
  • Responsible for handling technology transfer products in coordination with PD, QC, EN, R&D, RA, and AD.
  • Responsible for approval or rejection, as he sees fit, starting materials and packaging materials in consultation with Head-QC.
  • Responsible for monitoring and control of the manufacturing environment and plant hygiene.
  • Responsible for review of SOPs. Responsible for approval of the SOPs in the absence of QA-Head.
  • Responsible for review of Qualification / Validation data and preparation of reports.
  • Responsible for review and approval of master batch manufacturing records and batch packing records
  • Responsible for verification of vendor documents with respect to equipment/ instruments, utility, and HVAC area.
  • Responsible for approval of change request notes, and deviation with respect to equipment/instrument, Utility, HVAC / Facility area.
  • Responsible for approval of Specifications, Standard Testing procedures, General Test Procedures, Worksheets, and sampling instructions.
  • Responsible for review and Approval of executed exhibit batch/ Process validation batch manufacturing records.
  • Responsible for review and approval in investigation and handling of market complaints/ product recalls if any.

  • Responsible for review of quality Records of other departments.
  • Responsible for compliance of cGMP and maintain of Quality Policy
  • Responsible for conducting internal audit routine GMP inspection in the plant.
  • Responsible for monitoring and control of the manufacturing environment and Plant Hygiene.
  • Joint responsible with Head – Production, and Manager – QC in monitoring and control of manufacturing environment.
  • Joint responsible with Head – Production, and Manager – QC in monitoring and control of GMP compliance in plant
  • Joint responsible with Head – Production, and Manager – QC in monitoring and control of plant hygiene
  • Joint responsible with Manager – R&D, Manager – QC assessment and conclusion of stability studies
  • Responsible for compliance, adequacy, and verification of the Technology Transfer Dossier
  • Responsible for the final review of data/ documents compiled after execution of the exhibit batch.
  • Responsible for design and monitoring of storage conditions for materials and products.
  • Responsible for ensuring all necessary testing is carried out.
  • Responsible to check the maintenance of the department, premises, and equipment.
  • Responsible for approval of Site Master File and Validation Master Plan.
  • Responsible for approval of Technical agreements related to customers.
  • Responsible for Retention of documents.
  • Responsible for Handling and closure of QMS documents (Change controls, Deviations, Incidents, customer complaints, CAPA, Returned goods, OOS, OOT, Failure investigations, Product recalls, and Annual product review).
  • Responsible for Finished product releases and Rejections.
  • Periodic assessment of the vendors through conducting vendor audit and vendor approval

Qualification: B.Pharma