Quality Assurance Manager

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Basic Job Information
Job Category : Healthcare / Pharma / Biotech / Medical / R&D
Job Level :

Mid Level

No. of Vacancies :

1

Employment Type : Full Time
Job Location : Telkot, Bhaktapur
Offered Salary :
Negotiable
Apply Before(Deadline) :
Dec 22, 2020 (3 weeks 2 days 22 hours from now )

Job Specification
Education Level : Master Degree
Experience Required :
Greater than 3 Years
Other Specification

Job Description

 

  • Ensure local regulatory and GMP guidelines are being followed across all departments (QC, Formulation, Production etc.) at the site and external to the site, as applicable.
  • Prepare, review and/or approve and retain Master Formulation Record (MFR), Site Master File, Company Quality Manual, Company Quality Policy, Water Quality Manual, Quality Risk Management File, Validation Master Plan File, Master Copy of SOP, Master Copy of BMR/BPR, Water System Validation Protocol, process Validation Protocol.
  • Prepare, review and/or approve and retain formulation batch records, production batch records, batch deviations, master batch records, change controls etc.
  • Lead/support internal and external audits/inspections and prepare, review and retain Corrective and Preventive Action (CAPA).
  • Monitor all operations that affect quality.
  • Serve as the focal point for obtaining manufacturing/marketing license and for product recall, handling customer complaints and other related activities.
  • Assess new suppliers’ QA programs, as well as audit existing suppliers.
  • Design training materials and implement QA trainings for all relevant stakeholders.
  • Serve as the focal point for product design, formulations etc. as per applicable regulatory requirements.