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Manager QA/QA Auditors - GLP

8.00 to 13.00 Years   Hyderabad   06 Aug, 2021
SIPRA LABS LIMITED
Job LocationHyderabad
EducationNot Mentioned
SalaryRs 7 - 12 Lakh/Yr
IndustryPharma / Biotech
Functional AreaR&D / Product Design
EmploymentTypeFull-time

Job Description

Manager QA/QA Auditors - GLP

  • Maintaining copy of master study schedule.
  • Preparation and Maintenance of master list of SOPs.
  • Preparation and assuring the implementation of QAU audit schedule.
  • Conducting the audits and reviewing the audit reports submitted by QA- Executives and upon communicating with study director reporting to TFM regarding discrepancies.
  • Prepare and sign a statement, to be included with the final report, which specifies types of inspections and their dates including the phases of the study inspected and the dates were reported to the management, study director and principle investigator if applicable.
  • Assures the final report reflects the raw data.
  • Responsible for implementation of Quality Management System in Sipra Labs Limited.
  • Assures the effective implementation of SOPs.
  • Assures the Training of newly joined and existing employees based on the requirement.
  • Participate the internal and external training (GLP and any other) programs.
  • Assure the conduct of internal quality audits (facility based, study based, process based and including critical aspects/Phases) as per schedule.
  • Review and sign study plans for assurance in compliance with GLP.
  • Inspection of study during critical phases.
  • Inspection of Vendors, Contractors and Suppliers.
  • Inspection of raw data generated during the study.
  • Inspection and Review of draft and final report.
Qualification: M.Pharmacy, MScExperience: 8-12 Years for Manager3-5 Years for Auditors

Keyskills :
audit reportsquality managementquality assurancequality auditglpquality management systemsopassuranceinternal quality auditor

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