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Manager / Sr. Executive Quality Control

10.00 to 13.00 Years   Vadodara   11 Aug, 2019
Job LocationVadodara
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaSales / BD
EmploymentTypeFull-time

Job Description

  • Responsible for Analyst Qualification, Calibration, Qualification of Instrument/ Equipments, SOP, Column Management, Procurement and Capex, Preventive Maintenance, Computer system Validation, Audit compliance and Working standard activity.
  • Ensure planning and execution of all activity in GLP section.
  • Responsible for review of SOPs, GTPs, specification, Protocol for stability, Protocol of Analytical Method Validation/ Transferred/ verification and other non-routine activity.
  • Responsible for Approval of Calibration of Instrument/Equipments.
  • Responsible for Usage Decision for Calibration of Instrument/ Equipments through SAP and review of preventive Maintenance through SAP.
  • Responsible for Investigation of non-conformities like deviations, out of specifications, out of trend, failures, Market complains etc. and derive appropriate Corrective and preventive actions.
  • Responsible for execution and review of software validation documents.
  • Issuance of calibration data sheet and test data sheet for RM, PM, FP, INT and stability.
  • Responsible for Preventive Maintenance and AMC of Equipment and instrument.
  • Review of Temperature and Humidity record, Daily Monitoring Record, External Calibration Record, IQ, OQ, PQ record of instrument/Equipment.
  • Responsible for review of change control, deviation, CAPA, incident, Reprocess in QAMS.
  • Responsible for review of Effective Monitoring of CAPA.
  • Coordinate with RA for filling the requirements of various regulatory submissions.
  • Responsible for preparation of AMC/CMC PO.
  • Responsible for initiation of capex items.
  • Laboratory maintenance as per GLP compliance.
Required Candidate profile
  • Relevant Exposure in API/Bulk Drug /Pharma/ Industry with Process Safety implementation, Excellent Communication & Interpersonal Skills.
  • Scored 60% marks / 1st Class in their highest qualification, if having less than 05 years of post qualification experience.
  • Behavioral Attributes: Customer Focus, Effective communication skills, Execution Excellence, Building Positive Working relationship, Decision Making through strategic thinking, Achievement orientation, Developing others.
  • Physical Capabilities : Normal skin and appendages, no chest diseases no physical deformity/ disability/ disorder/ vision bilateral corrected, no color blindness, normal blood pressure, no communicable/ infectious/ occupational diseases.
Perks and Benefits Salary no bar for deserving candidates,

Keyskills :
computersystemvalidationeffectivecommunicationskillstestdataprocesssafetychangecontrolcustomerfocusbloodpressureauditcompliancestrategicthinkingsoftwarevalidationcommunicationskillsafetyimpl

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