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LATAM QA Auditor

3.00 to 6.00 Years   Mumbai City   06 Apr, 2021
Abbott Healthcare
Job LocationMumbai City
EducationNot Mentioned
SalaryNot Disclosed
IndustryRetail
Functional AreaSales / BD,Quality (QA-QC)
EmploymentTypeFull-time

Job Description

Primary Job Function :The role of the EPD Regional QA Auditor function is to manage suppliers qualification activities such as on-site audits and Quality Questionnaires, that fall under the responsibility of EPD LATAM Regional QA. The scope is Suppliers and Third-Party Manufacturers that provide materials, services and products to EPD LATAM. Suppliers can include API suppliers, contract testing labs, excipient suppliers, commodity suppliers and third-party manufacturers who provide intermediate/final products to EPD.Core Job Responsibilities :

  • Manage on site audit for materials supplier and Third-Party Manufacturers that provides materials/services to the region but located worldwide.
  • Conduct For Cause audits as and when required.
  • Perform QQ assessment whenever required for the potential suppliers/TPMs/Service providers.
  • To conduct Desktop audits/evaluation in case required.
  • Ensure compliance to current EQD requirements for Audit and compliance function.
  • Conduct Due-diligence/ Qualification audits of potential new suppliers/TPMs/services.
  • All activities required to plan, prepare for, conduct, report and close the assigned audits.
  • Ensure that all audit related information is documented into the Audit Tracking system in a timely manner.
  • Manage other qualification activities associated within the suppliers/TPMs within LATAM s management such as but not limited to Quality Technical Agreements.
  • Assess the appropriateness and timeliness of proposed CAPAs, and track CAPA follow-up to close for supplier and TPMs evaluated.
  • Timely information on the audits to management and stakeholders. Escalation of any critical findings or negative audit outcomes to EPD LATAM regional senior management, in line with the applicable policy and procedures.
  • Learn and extract developing regulations and trends from available sources to provide recent perspectives during audits.
  • Ensure a proactive determination of regulatory, compliance and quality issues and integrate them into audits/assessments on a priority basis.
  • Provide support to EPD LATAM plants in the timely resolution of issues related to regionally managed suppliers. Discuss with and agree with the supplier a timely implementation of corrective and preventive actions, as needed to prevent recurrence.
  • Management of LATAM Regional API suppliers claims from a QA perspective.
Supervisory/Management Responsibilities :No reports.Position Accountability / Scope :Reporting to Audit & Supplier QA Manager LATAM.Minimum Education
  • Bachelor s degree or equivalent level of education at a relevant scientific discipline (Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific), or industry experience with sufficient exposure to pharmaceutical or related industries.
  • Fluent English (writing and speaking).
  • Excellent communication skills.
  • The ability to work co-operatively and effectively within a multi-cultural and highly active team.
  • Adaptability to demanding and highly changing environments.
Minimum Experience/Training Required
  • Experience in GMP Audits of API suppliers and TPMs.
  • Knowledge and understanding of the ICH and other relevant technical guidelines, as well as GMP guidelines.
  • Understanding of the WHO and other applicable regional and local regulations
  • Good Communication skills
  • Proactivity and ability to work in a multi-cultural environment, with challenging deadlines.
  • Advanced written and verbal skills in Business English.
  • Competencies required: adaptability, initiative, integrity, planning & organizing, information gathering, analytical thinking, interpersonal understanding, cultural sensitivity, ethical behaviour, independence, decisiveness.
  • Availability for traveling (maximum 40-50% of the time)
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Keyskills :
on sitecapasgmpsenior managementclaimsdecodinginformation gatheringquality assurancecultural sensitivitypreventive actionscalibrationbioanalyticalsopplantscapaichlatamapiepd

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