Quality Assurance-Manager (QA Manager)

Posted 4 years ago

Pharma Consultants

Manager – QA

  • Responsible for coordinating with other departments as well as planning the day to day activities in the department with Executives
  • Shall be responsible for Quality Management System activities such as Change Controls, CAPAs, Market Complaints, Vendor Approvals, Self -Inspections, Batch Records, Product Quality Reviews
  • QA Manager :Shall review / approve BMR and BPR for new products or existing products
  • QA Manager :Shall be responsible for monitoring product performance through Product Quality Reviews and Stability Reports
  • QA Manager :Shall be responsible for SOPs preparation, Review & Approval
  • QA Manager :Shall be responsible for audit preparation, compliance reports and responses preparation and review of documents
  • QA Manager:Shall be responsible for conducting planned and unplanned Risk Assessments for various activities/processes in the facility.
  • QA Manager :Shall be responsible for conducting periodical trainings to the concerned subordinates or other departments.
  • QA Manager:Shall be responsible for review of all trend analysis of water validation, environment monitoring
  • QA Manager :Shall be responsible for monitoring and ensuring implementation of computerized systems in the facility.
  • QA Manager:Shall be responsible for preparation of documents related to regulated market.
  • QA Manager :Shall be responsible for review of Site Master File, Validation Master Plan, Department Manual, List of Master Documents, Technical Agreements
  • QA Manager :Shall be responsible person in absence of Head – QA to carry out specific duties

Job Features

Experience10-12 yrs
EducationB. Pharm , M. Pharm , B.Sc, M.Sc
IndustryPharmaceutical-Formulation Unit
SkillsQuality Assurance , QA, Audit exposures

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