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QA Head For Leading Pharma API Bulk drug Company in Vizag Location

20.00 to 25.00 Years   Vishakhapatnam   02 Sep, 2020
BVR People Consulting
Job LocationVishakhapatnam
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

Job Title: Quality Assurance (QA) Head Company: Leading Pharma API Bulk drug Company in Vizag Location Designation: GM & Above Reporting to: CEONo. of Positions: 1Division: API Bulk drugs Department: Quality Location: Vizag LocationQualification: MSc (Full Time)Years of Experience: 20 to 25 YearsSalary Range: OpenContact Person:Mr.Zabi MogalMobile: 7676936384 Email ID: zabi@bvrpc.comPlease Note: Candidate should be able to lead both QA and QC functions with slight edge on QAResponsibilities:REGULATORY/CUSTOMER AUDITS:

  1. Responsible for all regulatory audits such as USFDA, EDQM, MHRA, KFDA, ANVISA, PMDA and TGA as a prime auditee.
  2. Responsible for customer audits and ensuring to get minimum observations, specifically without any major/critical observations that may lead to data integrity.
  3. Should able to handle the audits independently and is accountable to respond on all regulatory queries.
QUALITY MANAGEMENT SYSTEM:
  • Implementation of Quality Management System at site.
  • Ensure compliance to Current Good Manufacturing Practices (CGMP)
  • Overall responsible for compliance to in-house and contract projects with respect to Manufacturing.
  • Responsible for closing the OOS reports by providing proper technical justification including a suitable CAPA.
  • Responsible for performing product reviews.
TRAININGS:
  • Ensuring training to all employees as per the schedule and imparting training to shop floor personnel as well.
  • Reviewing the training records and assessment sheets
INTERNAL AUDITS:
  • Ensure that the internal audits (self-inspections) are performed as per the schedule.
  • Responsible to make sure that all the critical deviations are investigated and resolved.
SOPs and APPROVALS:
  • Responsible for approving all departmental SOP s.
  • Responsible for reviewing specifications of raw materials, in-process, intermediate and finished drug substances, packing materials, labeling materials and standard test procedures.
  • Responsible for approving process validation, cleaning validation, purified water system validation, HVAC, Hold time stability protocols and reports.
  • Review and approve qualification protocols of instrument/equipment, Analytical method transfer protocols and reports.
MANUFACTURING SUPPORT:
  • Responsible for reviewing and approval of scale-up, technology transfer and development reports.
  • Responsible for maintaining online documentation
  • Responsible for reviewing, identifying the gaps and support to complete the executed batch records
  • Responsible for reviewing completed batch production and laboratory control records of critical process steps before release of the API for distribution.
  • Responsible for releasing or rejecting all API s and Intermediates.
  • Responsible for approving intermediate and API contract manufacturers.
  • Responsible for approving changes that potentially impact intermediate or API quality.
OTHERS:
  • Responsible for acting as Dy. Management Representative in the site.
  • Responsible for delegating works to In-Charge-QA in his absence.
Salary: Not Disclosed by RecruiterIndustry: Pharma / Biotech / Clinical ResearchFunctional Area: Production, Manufacturing, MaintenanceRole Category: Senior ManagementRole: Head/VP/GM-Quality Assurance/Quality ControlEmployment Type: Full Time, Permanent , Education:UG -B.Sc - Any SpecializationPG - MS/M.Sc(Science) - Any Specialization

Keyskills :
quality controlmusic makingshop floorpurified watercustomer auditsinspectioncomplianceregulatory auditsisomanagement systemauditingquality managementcontinuous improvement facilitationquality management systemraw materialsprocess validation

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