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Senior Of Executive/ Assistant Manager Quality Assurance

6.00 to 11.00 Years   Other Maharashtra   25 Mar, 2019
Gennext Human Resource managment Hiring For Gennext Human Resource managment
Job LocationOther Maharashtra
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional Areauality (QA-QC)
EmploymentTypeFull-time

Job Description

Responsibilities:

  1. Review & Approval of QMS documents. (Change Control/ Deviation/ CAPA/ OOS).
  2. Review of BMR/ BPR/ ECR review & approval.
  3. Approval of Site Master File (SMF) & Validation Master plan (VMP).
  4. Handling of Market complaints & returned materials.
  5. Performing Process & Cleaning Validation.
  6. Review and approval of OOS / OOT.
  7. Handling of Customer Audits.
  8. Qualification: Process equipment, AHU (HVAC) & Water System.
  9. Equipment Qualification (URS, DQ, IQ, OQ & PQ).
  10. Performing Internal audits / Self Inspections.
  11. Performing Vendor Audits.
  12. Preparation of approved vendor list.
  13. Performing training (On job, department SOPs, cGMP).
Skills:
  • Relevant experience in API manufacturing facility.
  • Having USFDA/ EDQM/ WHO audit experience.
  • To update Daily Documents, Records.
  • Good Communication Skills.
  • Should be able to handle a team.

Keyskills :
qmsqualityoperationsmanufacturingvalidationbprapicustomerservice

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