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Audit manager @ Golden Opportunities

Home > Quality Control Manager

 Audit manager

Job Description

Job opening in a leading MNC - Audit manager / Mumbai
Job Title: Audit and Inception Manager
Educational Qualification: University/college degree BA/BS (life science preferred) or equivalent
Salary best in industry
Candidates Specification:

  • GXP Quality control and GCP Audit experience
  • Experience in PV
Job Description :
  • Must have 4+ years of experience in GXP Quality Control and GCP Audit Experience
  • Responsible for supporting internal external regional and global QA audits per Standard Operating
  • Procedures and Master Audit Plan assuring that audited systems processes and their outcomes
  • comply with applicable international and national regulations and guidelines and fulfil client requirements.
  • Lead audit teams in the conduct reporting and follow up of regional and global QA audits ensuring
  • compliance to applicable SOPs Master Audit Plan and within specified timeframes and quality standards
  • Provide suitable recommendations for audit observations; ensures auditees deliver appropriate
  • CAPAs and follows them up through closure. Escalates as appropriate were resolution of audit findings is inadequate
  • Proactively identifies and leads process improvement activities/SOP creation and revisions
  • Able to host client audits and able to support regulatory inspections
  • Leads and/or participates in special projects
  • Thorough knowledge understanding and experience applying ICH Guidelines GCPs including
  • applicable regulatory requirements for the conduct of clinical development programs
  • Knowledge of the drug development process

Employement Category:

Employement Type: Full time
Industry: Bio Technology & Life Sciences
Functional Area: Pharmaceutical
Role Category: Quality Control Manager
Role/Responsibilies: Audit manager

Contact Details:

Company: Golden Opportunities
Location(s): Chennai

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