Specialist
- NOVARTIS
- 2 - 7 years
- Hyderabad
- 2 months ago
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Job Description
Summary
-Manages Quality aspects and projects within area of responsibility. -Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems.
About the Role
Major accountabilities:
- Oversight of all production and testing activities, ensures compliance with cGxP, incl. 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 -Executes batch release in compliance with registration
Minimum Requirements:
Work Experience:
Work Experience:
- Functional Breadth.
- QC/ QA in pharmaceutical ind./ biotech with environmental monitoring &.
- Collaborating across boundaries.
- cleanliness zones.
Skills:
- Continuous Learning.
- Dealing With Ambiguity.
- Gmp Procedures.
- Qa (Quality Assurance).
- Quality Control (Qc) Testing.
- Quality Standards.
- Self Awareness.
- Technological Expertise.
- Technological Intelligence.
Languages :
- English.
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Quality AssuranceRole Category: Business Process QualityRole: Quality SpecialistEmployement Type: Full timeContact Details:
Company: NOVARTISLocation(s): Hyderabad+ View Contact
Keyskills: OPEX QC Quality standards Manager Quality Assurance Compliance Pharma Manager Quality Control GMP Continuous improvement Environmental monitoring
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