Quality Control Specialist (Temp.)
About this role
Job Description Summary
-Highly skilled and experienced laboratory professional who contributes by performing analytical release testing, investigational support, research support, and stability testing.Job Description
Major accountabilities:
- OOx/Deviation handling.
- CAPA definition -KPI trending -Ensure all activities in compliance with cGxP, incl. data integrity review and approval of analytical data / tests (analytical release) Stability -Stability testing (Projects) – protocol preparation, evaluation, report preparation.
- Reporting (Stability plan preparation, trend analysis, evaluation) -Performance of Stability studies, protocols and comparative reports for supplier qualification -Review and approval of analytical tests (analytical release) -Microbiological QC -Perform Microbiological testing of materials and utilities, environmental and personnel monitoring -Provide expert Support for site qualification and validation activities -Maintain and calibrate equipment incl. plan preparation -Support in supplier qualification -Trending and analysis of KPI/KQI -Support sample planning and sampling execution -Reporting of technical complaints / adverse events / special case scenarios related to Sandoz products within 24 hours of receipt -Distribution of marketing samples (where applicable)
Key performance indicators:
- The relevant KPIs that are defined in the Quality Control areas apply: e.g. analytical lead times -Timely and GMP-compliant analysis & documentation of the results.
- Error rate: Number of OOS (analysis errors) related to the number of analyzes -No complaints about official inspections.
- Individual performance is assessed using the PMP performance dialog together with the manager
Minimum Requirements:
Work Experience:
- Functional Breadth.
- 3-5years experience in Pharma/Manufacturing sector in analytical lab in.
- Collaborating across boundaries.
- A GMP environment/equivalent.
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 ManagementCompany at a glance
Sandoz is the global leader in generic and biosimilar medicines, with a growth strategy driven by its Purpose: pioneering access for patients.
More than 20,000 people of 100 nationalities work together to ensure 900 million patient treatments are provided by Sandoz annually, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,300 products addresses diseases from the common cold to cancer.
Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the world’s first biosimilar in 2006. In 2024, Sandoz recorded net sales of USD 10.4 billion.
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