QC Analyst IV

Job Description Summary

This role utilizes chemistry laboratory skills to test and measure product or materials while ensuring that analysis is performed according to established Standard Operating Procedures (SOPs), Analytical Methods & current Compendia.

Job Description

Major accountabilities:

• Sample storage and management - Analytical testing/documentation of drug product/finished product/complaints/stability/packaging material samples to GxP standards.
• Analytical documentation of stability samples to GxP standards - 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:

• Orders are processed correctly and quickly.
• No waiting times due to wrong or delayed order.
• Deadline adherence rate: orders completed on time, all missed deadlines reported in good time, the shortest possible lead time.
• Ensure constant readiness for inspection, no critical complaints from superiors and inspectors.
• Consistently follow the GMP and GSU guidelines, as well as the SOPs, no critical irregularities.
• Finding and implementing optimization options to reduce costs.
• Completed training plan.

Minimum Requirements:

Work Experience:

• Sound technical & scientific knowledge of pharmaceutical/chemical.
• Working experience in Laboratory environment in the Pharmaceutical analytics/QC/equivalent industry.

Skills:

• Continuous Learning.
• Dealing With Ambiguity.
• Decision Making Skills.
• Gxp.
• Industry Standards.
• Laboratory Equipment.
• Laboratory Excellence.
• Quality Control (Qc) Testing.
• Quality Control Sampling.
• Self Awareness.
• Technological Expertise.
• Total Quality Management.

Languages:

• English.

Skills Desired:

• Continued Learning.
• Dealing With Ambiguity.
• Decision Making Skills.
• Gxp.
• Industry Standards.
• Laboratory Equipment.
• Laboratory Excellence.
• Quality Control (Qc) Testing.
• Quality Control Sampling.
• Self-Awareness.
• Technological Expertise.
• Total Quality Management.