Quality Operations Specialist

5 days ago


Hyderabad Secunderabad Telangana Nizamabad Warangal, India beBeeQuality Full time

Job Description:

We are seeking a skilled professional to perform Quality Operations services in support of product quality compliance and regulatory workflows. This role involves delivering high-quality services, holding accounts in workflow applications, generating and analyzing reports, and escalating service-related issues.

Responsibilities:

  • Perform Quality Operations services to ensure product quality compliance and regulatory workflows
  • Hold accounts in workflow applications to execute service deliverables
  • Generate and analyze reports in various applications
  • Escalate service-related GxP and non-GxP issues and investigate
  • Ensure compliance to internal quality standards, regulatory requirements, and service level agreements
  • Comply with internal functional operating procedures like time tracking, KPI reporting, and ticket management

Annual Product Quality Review (APQR) Responsibilities:

  • Extract data from Novartis tools and applications
  • Interpret and compile external supplier APQR and internal data into a template
  • Collect contributory reports for product evaluations
  • Interact with CMOs and manufacturing sites as required
  • Support updating and maintenance of APQR schedule
  • Review APQR report/data for completeness and accuracy

Ideal Background/Requirements:

  • M.Pharm/MBA/Engineering/equivalent degree from a reputable institution
  • Minimum 1 year experience in Quality Assurance, Regulatory, or pharmaceutical manufacturing
  • Basic awareness of GxP compliance requirements

Skills Desired:

Key Skills: Continued Learning, Dealing With Ambiguity, Gmp Procedures, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence

Contact Information: Not Applicable



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