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Monday, February 29, 2016

QA - Liva Pharmaceutical, Zydus, Injectable, Vadodara FEB 2016

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DesignationHead ( DGM) - QA - Liva Pharmaceutical, Zydus, Injectable, Vadodara - 1 Opening(s)
Job Description

  • To head Quality Assurance of formulation Injectable manufacturing facility. 
  • To approve the Standard Operating Procedures pertaining to manufacturing and control of drug products.
  • To approve master production and packing records.
  • To approve specifications, sampling instructions, test methods and other quality control procedures.
  • To ensure that internal audit (Self-inspection) are performed and compliance is ensured.
  • To approve changes in the manufacturing process, specifications, testing procedures, systems, operations, facility, documents etc.
  • To ensure that appropriate initial and continuing training of SOPs and other cGMP topics is carried out.
  • To ensure that all the necessary in process quality assurance activities are carried out.
  • To ensure compliance of cGMP in the manufacturing, packing and release of drug products.
  • To ensure that appropriate validations are done.
  • To review and approve validation protocols and reports.
  • To ensure that effective system are used for maintain and calibrating critical instruments.
  • To ensure that effective system is in place for maintenance of equipment.
  • To approve qualification protocols and reports.
  • To ensure review of completed Batch Manufacturing Records for critical process steps before release.
  • To ensure that quality related complaints are investigated and resolved.
  • To ensure that product failures are investigated and resolved.
  • To ensure vendor evaluation/audits of Raw & Packing Material suppliers.
  • To approve art works.
  • To ensure that product sampling is performed as per Standard Operating Procedures.
  • To ensure that deviations are investigated appropriately and CAPA is implemented.
  • To ensure product quality reviews are performed at regular intervals.
Desired Profile
  • Hands-on expertise of handling Quality Assurance function at large scale Formulation (Injectable) Pharma manufacturing facility in an environment of increasing regulatory complexity.
  • Exposure of Lyophilisation 
  • Exposure of setting new labs with proper documentation and as per GLP standards.
  • Should have worked in Senior Management level heading Quality Assurance function in regulated plants having approvals of US FDA, MHRA. etc.
  • Should carry rich experience of IPQA, QMS, Method Validation, Method Transfer, Documentation, in large scale Formulation Pharma manufacturing facility. 
  • Hands-on experience in successfully handling and implementing cGMP (Current Good Manufacturing Practice) in Quality Assurance across different layers of the site.
  • Must have an established track record of successfully facing Regulatory audits. 
  • Working closely with Quality & Regulatory functions to create a highly compliant environment.
Experience15 - 20 Years
Industry TypePharma / Biotech / Clinical Research
Functional AreaOther
EducationUG - B.Pharma - Pharmacy
PG - M.Sc - Chemistry, M.Pharma - Pharmacy
Doctorate - Doctorate Not Required
Compensation: 25,00,000 - 30,00,000 P.A
KeywordsInjectable sterile QA Quality Assurance IPQA Validation Method Validation QMS
ContactRuchir Someshwar
Cadila Healthcare Limited 
Job Posted2016-02-27 13:18:20.0


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