Common Accountabilities (Applicable to all service teams)
- 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, etc.) to ensure appropriate execution of service deliverables
- Generate and analyse predefined and ad-hoc reports in various applications (like 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
- Ensure compliance to the Novartis internal quality standards, relevant regulatory requirements, filed product quality standards and service level agreements
- 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.
- 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 the accuracy and timeliness of deliverables
- Comply to the applicable Novartis operating procedures as per legal / IT / HR requirement
- Provide active support during internal and external audits by collecting and presenting the requested process data/reports
- Adhere to the current GxP and compliance policies of Novartis.
ROLE SPECIFIC ACCOUNTABILITIES ACROSS ALL FUNCTIONS IN QOP
Annual Product Quality Review
- Extract data from relevant sources in Novartis tools/ applications.
- Interpret and compile external supplier APQR and/ or extracted data from Internal Novartis systems into a pre-defined template and draft conclusion of product quality review.
- Collect contributory reports for product related evaluations.
- Interact with CMOs and / or manufacturing sites as required.
- Support in updating and maintenance of APQR schedule.
- Perform review of APQR report/ data as applicable to ensure it is complete and correct.
- Complete APQRs within defined timelines.
- Archive the approved APQR as applicable
- Update APQR data in e-compass file followed by interpretation of data to conclude product robustness.
- Marketing Authorization Holder (MAH) Review:
- Support in maintenance of MAH/BRS review schedule
- Coordinate with NCQ SPoCs and/ or manufacturing/ packaging/ testing/ batch releasing sites as required to draft MAH/BRS checklist
- Extract data from relevant sources as applicable and compile MAH/BRS as per the requirements in a predefined format
- Interpretation and consolidation of the data
- Review for accuracy and completeness of compiled data /information
- Submit the drafted MAH/BRS reviews for approval to respective Country quality team
- Archive the approved MAH/BRS review documents
Ideal Background / Requirements for the role
- M.Pharm/ MBA / Engineering/equivalent from a reputed institute.
- Min 1 yr Experience in Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substances or products/ Medical device.
- Basic awareness of GxP compliance requirements.
Skills Desired
Continued Learning, Dealing With Ambiguity, Gmp Procedures, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence
