Required for Executive Quality Assurance in Zoetis,,"R"

Required for Executive Quality Assurance in Zoetis..

 Executive Quality Assurance

Job Description: 
Job Responsibilities

• Handling of In-Process Quality Operations and IPQA team.
• Review of Batch Manufacturing Record (BMR) and Batch Packaging Records (BPR) and Batch Release activity.
• Handling of change controls, deviations, incidents, batch failure investigations, CAPA and market complaints.
• Preparation and review of Annual Product Reviews (APRs).
• Preparation and review of Quality Assurance (QA) and Validation relatedStandard Operating Procedures (SOP).
• Audit of vendors, self audits, preparation of audit reports and to ensure compliance.
• Preparation and maintenance of validation master plan, Calibration master plan, Validation/ Qualification Protocols and Summary reports.
• Preparation review and execution of process validation protocols and reports.
• Process validation for Tablet, Liquid oral and Injection products. Asepticprocess simulation (media fill), validation of filtration, sterilization and depyrogenation processes.
• Planning of calibration activities of instruments and coordination with external agencies for timely calibration and related documentation.
• Strong knowledge on packaging validations and utilities (HVAC, Water, Compressed g
• Education and Qualification
  Essential: B. Pharma or M. Sc (Microbiology)
  Desirable:
  Exposure to USFDA, MHRA audits.
  Strong communication and writing skills.
  Local or nearby Haridwar region.
  Exposure to Six Sigma, Total Quality Management (TQM) or Total Productivity Management (TPM) related activities
  Work Experience
  6 to 8 years of work experience in Quality Assurance and Validation related activities.
  Skills and Competencies
  Ability to handle a team and should have managerial skills.
  Strong communication and convincing skills to inculcate the validation practices and understanding among the team members and peers.
  Updated on current trends in QA and Validations
  Additional Information:
  Experience: 6-8 Year
  Location: Haridwar
  Job Ref: 10611688
  Industry Type: Pharma/Biotech/Clinical Research
  Functional Area: QA
  End Date: 31^st Dec., 2013