Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : Expert - Quality Operations
Job Description
Provide expert process knowledge supporting services within Quality Operations to ensure PLS-M&SO delivery is in compliance with customer requirements, cGMP regulatory requirements and the Novartis Pharma Quality Manual & Policies.
Responsibilities:
• Monitor, classify and log all technical communication types including initial requests, M7 requests, SRM outgoing mails and supplier returns/queries. Send detailed technical responses when required including from general queries, follow-up actions or corrections.
• Upload relevant data in a timely manner such as emails, excel, reports or other and create appropriate technical metadata. Perform periodic data reviews from backups and perform error correction if required.
• Perform Cohort of Concern (CoC) chemistry reviews of supplier data and create high level assessment reports in a timely manner. Liaise with CHAD where potential risks are identified.
• Create CoC full assessment reports including high level assessments or other as required. Submit finished documents to VIPER system with appropriate naming convention.
• Create summary statistics and dashboard graphs based on existing SharePoint files (evidence based tracking). Display complex and detailed information when required.
• Actively participate in technical group discussions, adhering to any actions on a daily basis. Communicate specific features when required, including detailed tracking information or actions emerging from dashboard observations..
• Author and review GxP and non-GxP documents and reports like trends, performance, qualification, validation, quality events and technical investigations.
• Generate and analyze predefined and ad-hoc reports in various applications (like AGILE PLM, AQWA etc.) and perform follow-up actions if required.
• Monitors, reports and troubleshoot on process, data and system integrity & performance, in order to proactively drive, together with internal PLS stakeholders, adherence to the defined process within the organization, as well as to achieve excellence in the process and system.
• Provide process expertise to support new service or expansion projects, SLA negotiations, monitor and report progress and deviations, as appropriate.
• Act as project lead or first level escalation contact point for customers and team members for any service issues and lead related process investigations to ensure compliance with local and global operating procedures, SLA and customer expectation.
• Serve as a process expert during customer and internal audits and follow up on implementation of agreed CAPAs.
• Collect and communicate the appropriate KPIs and metrics used to monitor process performance and project progress
Candidate Profile
University or academic degree in Chemistry, Microbiology, Biotechnology, Pharmacy or equivalent English Experience in chemical/pharmaceutical industry. Min. 8-10 yrs Experience in Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substances or products.
Additional Information
Experience : 8-10 year
Qualification : B.Pharm, M.Sc, M.Pharm
Location : Hyderabad, AP
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Technical Operations
End Date : 20th June, 2019
See All Ph.D Alerts M.Pharm Alerts B.Pharm Alerts MBA Alerts
See All Other Jobs in our Database
.png)
