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Document Publishing @ Golden Opportunities

Home > Quality Assurance - Manager

 Document Publishing

Job Description

Candidate Specification:
Preferred Educational Qualification for the role: Bachelors degree in Life Science
Preferred experience for the role: Minimum 5 Years
Role: Team Leader
Responsibilities:

  • Perform quality check (primary/secondary/PEER) in line with customer provided SOPs and checklist for Clinical and Safety Reports.
  • Leverage customer SOPs and perform quality check (primary/secondary/PEER) for submission readiness of References and prepare citations for inclusion under 'References' section of various types regulatory submission documents.
  • Handle transaction processing on need basis for time sensitive or critical to quality requests.
  • Provide extended support on need basis depending on customer/process requirement
  • Build effective and high performing team through integration motivation and optimizing team performance.
  • Provide support and allocate specific process tasks to each associate.
  • Provide/manage specific training to team members to ensure performance in their area of responsibility contribution to and participation within the team activities.
  • Coach and support associates to ensure performance is optimized in the process.
  • Develop and maintains effective working.
  • Manage the domain metrics and proactively identifies resource quality and timeline issues.
  • Escalate issues that would impact the process delivery to the appropriate level to ensure resolution and implementation of any corrective action plan.
  • Ensure quality of data by regular checks during the process.
  • Maintain awareness of internal and external regulatory activities.
  • Ensure the training of team members on updated / revised SOPs.
  • Provide expertise to Domain team on the technical aspects of the process as well as general ICH GCP.
  • Provide regular status reports to Project Manager.
  • Ensure adequate resource of the project throughout its lifecycle.
  • Participate in recruitment and selection process.
  • Monitor and track SLAs on a project basis.
  • Develop and maintain team training plan scheduling training for new team members.
  • Monitor performance of new/existing associates throughout the support provided to customer completing various action items.
  • Ensure access to all relevant systems and tools has been obtained for team members.

Employement Category:

Employement Type: Full time
Industry: Pharmaceutical
Functional Area: Public Relations
Role Category: Quality Assurance - Manager
Role/Responsibilies: Document Publishing

Contact Details:

Company: Golden Opportunities
Location(s): Chennai

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