Quality Operations

Job Description

Position - Quality Operations Analyst Ideal Background / Requirements for the role: • M. Pharm/ MBA / Engineering/equivalent from a reputed institute. Skills- QMS elements from Pharmaceutical Quality Assurance Change Control is primary preferable however others can also be taken into consideration hands on exp on QMS tools AQWA, Trackwise, SAP Location- Hyderabad Duration- 1year Preferably local/ Hyderabad work mode- Hybrid 3 days in office , general shift Budget- up to 8.5 LPA Min 2-6 yr Experience in Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substances/ products/Medical device. • GMP -knowledge, Broad IT-knowledge • Fluent in English (written and spoken) • Good communication, presentation and interpersonal skills • Experience of working closely with the global stakeholders Roles & Responsibilities: Common Accountabilities: (Applicable to all services in QOP) • Comply with internal functional requirements such as KPI reporting, ticket management tools and any other internal procedures and processes • Assist the department on any other ad hoc activities/ requests to meet the business requirements • Regularly communicate with partners and obtain feedback on services delivered • Focus on timely completion of all relevant and assigned trainings • Learn & develop understanding to generate insights through data and digital Ensure responsibility and ownership of the assigned tasks • Comply with accuracy and timeliness of deliverables Comply to the applicable Novartis operating procedures as per legal/ IT/ P&O requirements • Create and review GxP documents including SOPs, working procedures, trend reports, qualification reports and technical investigations, as and when needed • Provide active support during internal and external audits by collecting and presenting the requested process/ data and reports • Adherence to the current GxP and compliance policies of organization Perform and deliver Quality Operations services in support of product quality compliance and regulatory workflows • Hold accounts in workflow applications (such as SAP, Dragon, SUBWAY, TEDI etc.) to ensure appropriate execution of service deliverables • Generate and analyze predefined and ad-hoc reports in various applications (such as AGILE PLM, AQWA etc.) and perform follow-up actions if required • Escalate service related GxP and non-GxP issues and ensure timely investigation and compliance with local and global operating procedures • Support implementing service quality and process improvement projects, CAPA management within Quality Service Centers • Comply with all internal functional operating procedures like time tracking, KPI reporting, ticket management tools and other internal systems and processes • Assist the department on any other ad hoc administrative activities as per business requirements Regularly communicate with customers and partners to collect feedbacks on support services, report deliverable • Oversight on BOT regular performance and support the BOT validation activities as per business need • Support the Master Data Management to the required sites as required Change Control Management: • Manage different types of change control like product stewardship/Administration Stewardship/Asset Stewardship in electronic systems like TrackWise and/or Agile from Change Initiation to closure as needed • Generate and analyze predefined and ad-hoc reports in various applications and perform follow-up actions as required. Perform Regulatory assessment on Change Controls as needed. Perform deviation investigations and CAPAs as part of change management. • Artwork Second Independent Check/M05 or Artwork Second Independent Text Reviewer or Approver Interested candidates share cv : busiraju.sindhu@manpower.co.in Whats App : 7013970562