Sandoz become a standalone organization! As a global market leader in Generics and Biosimilar medicine, Sandoz is stepping forward from a position of strength! Those joining Sandoz in the coming months will help shape the future of the company, it’s growth, innovation, culture and how Sandoz impacts the lives of millions. These will be careers with genuine impact! This is one such role.
Post : Manager Quality Compliance & Operations
Job Description :
• Shop floor Activities :
1. QA point of contact for the development laboratory associates whenever a QA inputs is needed, necessary, and requested.
2. Review and approval of SOPs related to development laboratory topics and review of guidance documents/ work procedures.
3. Support for/ approval of Risk Analysis and Assessments.
4. Support for digital systems implemented at site
5. Approval, respectively support for the approval of records (Deviations, OOS etc, Change Controls und Quality Events).
6. Approval of non-project related suppliers and preparation of respective Quality Agreements.
7. Support during inspections and audits as Analytical QA SME.
8. Perform approval of equipment qualification documentation.
9. Perform approval of facility qualification documentation.
• QMS Compliance Activities :
10. Implement the Novartis Quality Manual in Development locally (Sandoz Development Centre India).
11. Drive the implementation of relevant Global Standards & Procedures and the creation of a respective Quality framework (e.g., document management system and training system) to be able to compile and implement local GMP/ non-GMP procedures and documents.
12. Develop & execution of self-inspection in the SDC INHY laboratories and compilation of the respective report and support regarding the follow-up of the CAPA plan.
13. Prepare and facilitate the timely execution of site quality action plan.
14. To act as a lead for Data Integrity from Quality; along with business representative prepare and facilitate the timely execution of DI action plan for site.
15. Responsible for conducting & supervising Quality Review Board Meetings & actions.
16. Hosting Inspection and audits for SDC INHY as a QA Compliance SME and support regarding the follow- up of the CAPA plan.
17. Represent Site & participate in Global Quality compliance meetings.
18. To act as a Site Training Lead; along with business training leads prepare and facilitate the timely execution of trainings as per defined Training Matrix.
19. Conduct GxP quality related trainings.
20. Act as Key user for various quality IT platforms like exception management system
21. Immediately calls out quality and compliance issues to SDC Quality Management.
22. Any other task assigned by the management to support the team.
• Project Compliance Activities :
23. Participates in all project team meetings/discussions to provide quality compliance support and guidance to the project team. Defines the project quality tasks and quality standard for the project. Coordinates the product development from a quality perspective.
24. Participates in due diligence visits of Suppliers/CMOs/ CROs. Evaluates their quality standard and availability of a local manufacturing license whenever required from Projects
25. Is on the ground for the production of non-commercial batches (e.g., technical batches and registration/ validation batches) and in this regard cooperates/ aligns with the Quality organization of the Contract Manufacturing Organization (CMO) or any other Sandoz/Novartis network Technical Operations Site
26. Reviews and approves, if necessary, rejects the respective quality documents of the projects, e.g. Master Batch Records, performed batch records, other manufacturing documents, Process Validation documentation, Method Validation Protocols/ Plans and Reports, Stability documentation, study protocols and reports regardless if these documents are internally and externally created.
27. To do so requests associated data such as analytical test results, water testing data, environmental monitoring data (as applicable) regardless of the format of the data (charts, forms, printouts).
28. Reviews OOSs, Deviations, CAPAs, Change Controls in relation to the development projects. Verifies that all excursions from written procedures have been documented and explained according to the respective quality incident reporting procedure(s).
29. Disposes each batch of registration product manufactured by CMOs or SPC and therewith cooperates with the relevant Quality function at the CMOs or SPC.
30. Preparation of product launch – support of Pre-Approval Inspection (PAI) and definition of CMO preparation programs for PAI.
31. Supports the creation of audit plans for both internal and external audits.
32. Supports self-inspections to assess the current general compliance status of the Development Center with GMPs and relevant corporate policies. Supports the issuing of self-inspection reports and advises SDC Leadership Team immediately of any significant issues found during the inspection.
• Desired a Postgraduate in Pharmacy or equivalent with minimum 10 years of QA operations experience in a pharmaceutical, biologics or sterile, OSD products manufacturing facility and/or R&D quality including technology transfer of product to manufacturing sites
• Ability to transfer knowledge and educate GMPs. Auditing experience and experience in handing inspections is a plus. Detailed knowledge of GxP, regulatory guidelines, and quality management.
• Broad and in-depth understanding of drug product development and good understanding in the area of tasks and responsibilities within the SDC. Adequate presentation and scientific/ technical writing skills.
• Strong organizational and communication skills.
• Good analytical and critical thinking, pay attention to details.
• Knowledge of software and computer tools relevant for pharmaceutical development.
• Experience in an international matrix organization.
• Good interpersonal skills, Inter-cultural savvy
Experience : 10 years
Qualification : Postgraduate in Pharmacy
Location : Hyderabad, AP
Industry Type : Pharma / Healthcare / Clinical research
End Date : 30th September, 2023