Qa Manager & Qualified Person

Job Description Summary
Responsible for managing quality aspects within area of responsibility and to ensure that the operational business is in compliance with cGMP (Current Good Manufacturing Practices), the Quality Assurance Agreement, regulatory requirements and the Novartis Quality Manual and is conducted according to the relevant Standard Operating Procedures.
Job Description
Major accountabilities:
Oversight of all production and testing activities, ensuring compliance with cGxP, including data integrity and eCompliance.
Support exception investigations.
Review and approval of production, QC, and AS and T records.
MBR review.
Support OpEx improvement projects.
Qualified Person – Executes batch release in compliance with registration.
Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt.
Distribution of marketing samples (where applicable).
Key performance indicators:
On-time and GMP-compliant release of dosage forms.
No complaints about inspections by authorities in your own area of responsibility without these being noticed and communicated beforehand.
Successfully support continuous improvement projects.
Minimum Requirements:
Work Experience:
Critical Negotiations.
Functional Breadth.
Project Management.
People Leadership.
Collaborating across boundaries.
Operations Management and Execution.
Skills:
Continuous Learning.
Dealing With Ambiguity.
Employee Performance Evaluations.
GMP Procedures.
People Management.
QA (Quality Assurance).
Quality Control (QC) Testing.
Quality Standards.
Self Awareness.
Technological Expertise.
Technological Intelligence.
Languages:
English.
Skills Desired:
Continuous Learning.
Employee Performance Evaluations.
GMP Procedures.
Managing Ambiguity.
People Management.
QA (Quality Assurance).
Quality Control (QC) Testing.
Quality Standards.
Self-Awareness.
Technical Knowledge.
Technological Intelligence.

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