About Us
Novartis was created in 1996 through a merger of Ciba-Geigy and Sandoz. Novartis and its predecessor companies trace roots back more than 250 years, with a rich history of developing innovative products. From beginnings in the production of synthetic fabric dyes, the companies that eventually became Novartis branched out into producing chemicals and ultimately pharmaceuticals.
Specialist – Quality Operations
- Qualification: M. Pharm/ MBA / Engineering/equivalent from a reputed institute
- Experience: 4+ years’ experience in Quality Assurance, Regulatory or in the manufacturing
- Work Location: Hyderabad, AP
Your key responsibilities:
Your responsibilities include, but not limited to:
- Perform and deliver Quality Operations services in support of product quality compliance and regulatory workflows. Hold accounts in workflow applications (like SAP, Dragon, SUBWAY, TEDI etc.) to ensure appropriate execution of service deliverables.
- 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.\
- Responsible for the extraction and data compilation of analytical, manufacturing (including deviations, complaints, and change requests) and regulatory data (HA commitments, variations) in a predefined format.
- Responsible for collecting stability data and reports for product related evaluations. (e. g. compliance Investigations, divestitures, product transfers, validation. Etc. Support maintenance of APR/PQR schedule.
- Follow-up and tracking of complaint sample availability from Country Organization (CO) to CMO (Contract Manufacturing Organization). Send technical complaints to CMO for investigation. Perform queries in AQWA/Trackwise as per the SOP.
- Perform Quarterly compliant trending and reporting. Perform the role of QA approver for customer complaints delegated to QSC through delegated action.
- Perform a role of change control coordinator or change phase manager in change control management systems like TrackWise and AGILE. Manage different type of change control like product stewardship/Administration Stewardship/Asset Stewardship.
Commitment to Diversity & Inclusion:Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Minimum requirementsWhat you’ll bring to the role:
- M. Pharm/ MBA / Engineering/equivalent from a reputed institute.
- 4+ years’ experience in Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substances/ products/Medical device. GxP-knowledge, Broad IT-knowledge
- Good communication, presentation and interpersonal skills. Experience of working closely with the global stakeholders
- Experience on MAH review, quality compliance management, technical learning & document management system, product release support, stability support services.
Vigilance Quality Excellence Expert
- Qualification: PharmD, MSc degree in life sciences or equivalent.
- Experience: 2 to 4 years of experience in the pharmaceutical industry
- Work Location: Hyderabad, AP
Your responsibilities include, but are not limited to:
- Lead projects to enhance the methodologies and processes used to monitor and improve safety case and aggregate report quality. Lead the preparation and maintenance of manuals and other documents related to quality monitoring.
- Ensure safety cases and aggregate reports meet global Health Authority requirements and Novartis quality standards by- Leading quality sampling activities; Performing regular calibration activities; Resolving issues/queries and; Reviewing assigned aggregate reports and/or safety cases to confirm accurate and complete.
- Managing the online/offline Quality Check (QC) portfolios; Working with process owners and safety system experts to identify and implement new checks required in the Novartis safety database in response to process changes and overseeing timely completion of corrections.
- Performing follow up monitoring activities including those related to drug exposure during pregnancy. Performing trend analyses of the results of quality sampling, online/offline QC checks and monitoring activities.
- Leading investigations into the root cause of any deficiencies seen through trend analysis. Collaborating with process owners and other subject matter experts (SMEs) to develop and implement corrective and preventative actions (CAPAs) and, post implementation, verify the effectiveness of these.
- Preparing reports / presentations on aggregate report and/or safety case quality for CMO&PS management; Author and maintain procedural documents for assigned processes and drive continuous improvement by alignment of relevant stakeholders globally and locally.
- Be involved in creation and maintenance of training material and communications for Novartis group and third-party associates. Contribute to projects aimed at optimizing methodologies and processes to monitor safety cases and aggregate reports quality. Manage mailboxes in scope of responsibilities; triage emails and respond/ forward queries as appropriate.
- Perform reconciliation of safety information exchanged with global license partners to confirm completeness, investigation into any gaps identified and completion of remedial actions. Act as a subject matter expert during inspections (e.g., FDA and EMA) and audits and support with post audit/inspection activities including drafting of responses to any findings and the implementation of CAPAs. Train and mentor new CMO&PS associates and associates from other global line functions.
Commitment to Diversity & Inclusion:Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Minimum requirements
- PharmD, MSc degree in life sciences or equivalent.
- Fluency in English. Knowledge of other languages desirable.
- 2 to 4 years of experience in the pharmaceutical industry, particularly pharmacovigilance. Experience in medical device vigilance desirable.
- Procedural document/ report writing experience
- Good analytical skills / proven ability to work with data
- Good communication and presentation skills
- Good organizational skills; Ability to mentor and coach