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Manager/ Senior Manager Quality Assurance

Secunderabad, Telangana
Job Code:
  • Biotechnology & Science
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Job Details

Roles and responsibilitiesPerform project documentation audits including CDL-Analytical method validation reports independently and also conduct supervisory review and approval and issue audit reports.Review and approve qualification/ validation documents.Provide support in preparing Briefing Book and support director QA for Management Review Meeting.Review SOPs (standard operating procedures), forms and formats applicable/originated at USP-India.Review and approve supplier evaluation dossiers including supplier screening, vendor registration forms.Implement and follow Quality Management systems such as deviation, Corrective and Preventive action (CAPA) and document control and assists laboratory investigation report(s) (LIR). Conduct independent investigations and respond to inquiries related to quality issues.Conduct internal audits independently/with a team of auditors, prepare reports and assess adequacy of CAPA.Conduct quality assurance activities in the laboratory area as directed by appropriate ISO standards, internal SOPs.Support trending of project documentation audits and identifies the most reoccurring and major issues and propose its correction and corrective action.Responsible to organize/conduct training to staff on ISO, Quality topics, QA orientation and in-house proceduresCoordinate and supports in preparation of external ISO audits (ISO/IEC 17025 and ISO 9001).Prepare weekly/fortnightly dashboards and monthly reports and keep track of audit observation trends, CAPAs, Deviations, LIR and other QA activities.Represents QA as the lead or support in process improvement teams or initiatives and provides suggestions for appropriate quality system improvement tools.Adhere and promote USP core values within the department and throughout the organization.
Additional Degree: B.Pharm. (Pharmacy)

Experience: 10-12


Quality Assurance/ Control
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