
Quality Operations Specialist
5 days ago
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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