- assurance that the product quality conforms with specifications and that production activity is compliant with novartis quality policy and gxp requirements. Ensure that relevant documentation is up-to-date and archived correctly. Ensure “state of the art” gxp know-how and future trends in the field of gxp.
about the role
major accountabilities:
1. ensure that all aspects of handling, manufacturing, and distribution of biopharmaceutical/pharmaceutical products comply with the novartis quality manual, the effective quality agreement, relevant gxp regulatory requirements, and local sops.
2. prepare, review, and check batch documentation for correctness and completeness; safely archive original documents for the prescribed period; plan, conduct, and monitor self-inspection schemes for all sections.
3. monitor actions and corrections accordingly.
4. conduct gxp monitoring on all sections, investigate noncompliance issues, and follow up on corrective actions.
5. archive relevant documentation and manage/approve critical quality issues (deviations, complaints, recalls, counterfeits, product tampering, stability failures, etc.) according to the quality agreement and the novartis quality manual.
6. ensure investigations are correctly executed and all required actions are taken timely.
7. escalate issues or instances of instability per the novartis escalation policy and initiate necessary market actions.
8. decide on escalation to senior management, lead global quality assessments, manage filing, and ensure change requests are managed according to sops from receipt to closure.
9. assess quality trends, drive continuous improvement, and maintain communication with regulatory and pharmaceutical authorities regarding gxp updates.
10. identify activities and regulatory areas requiring sops and initiate their introduction.
11. plan, initiate, and monitor gxp training for all employees periodically; be responsible for the annual training program and its implementation.
12. establish and maintain cross-functional contacts with peers, authorities, and support product launches in collaboration with bd and development teams.
13. ensure all drug products are released in accordance with specifications and regulations.
14. maintain coordinated contact with regulatory authorities, local partners, stakeholders, and global qa.
15. report technical complaints, adverse events, or special scenarios related to novartis products within 24 hours.
16. distribute marketing samples where applicable.
key performance indicators:
* implementation and continuous update of the local gmp/gdp quality system, with proactive risk mitigation.
* functional breadth and operational management/execution.
skills:
* change control
* dealing with ambiguity
* guideline adherence
* product release processes
* quality assurance (qa)
* quality management
* regulation knowledge
* technological expertise
languages :
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