Qc Senior Specialist I
1 day ago
**Summary**:
- Highly skilled and experienced laboratory professional who contributes by performing analytical release testing, investigational support, research support, and stability testing
**About the Role**:
**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 Novartis 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.
Division
Operations
Business Unit
Innovative Medicines
Location
Singapore
Site
Tuas South Avenue
Company / Legal Entity
SG12 (FCRS = SG012) Novartis Singapore Pharmaceutical Manufacturing Pte Ltd
Functional Area
Quality
Job Type
Full time
Employment Type
Regular
Shift Work
No
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
-
Qc Senior Specialist I
1 day ago
Tuas, Singapore Novartis Full time**Summary**: This role will be responsible to establish and ensure testing of drug substance release and stability testing including testing of intermediates in process control samples and lab operations are accordance with written testing SOP’s and local/international regulations. **About the Role**: **Key Responsibilities**: - Sample storage and...
-
Senior QA Specialist
3 days ago
Tuas, Singapore Pfizer Full timeQA Specialist (QC Support): - We are looking for individual who can work independently, have good interpersonal skill and good laboratory compliance. The incumbent will have the responsibility for QA operational oversight for the site Quality Control (QC) and ensures overall quality integrity of the chemical and microbiological laboratories to support the...
-
Qc Specialist I
1 day ago
Tuas, Singapore Novartis Full time**Summary**: This role will be responsible to establish and ensure testing of drug substance release and stability testing including testing of intermediates in process control samples and lab operations are accordance with written testing SOP’s and local/international regulations. **About the Role**: **Key Responsibilities**: - Sample storage and...
-
Qc Analyst
2 weeks ago
Tuas, Singapore Novartis Full time**Summary**: Questo ruolo utilizza le competenze di laboratorio di chimica per testare e misurare prodotti o materiali, garantendo al contempo che l'analisi venga eseguita secondo le procedure operative standard (SOP), i metodi analitici e gli attuali compendi. **About the Role**: Major Accountabilities ~ Esempio deposito e management ~ Test...
-
Qc Analyst I
2 weeks ago
Tuas, Singapore Novartis Full time**Summary**: - Supports all activities within the assigned Quality department. Contributes to the implementation, maintenance, and execution of the assigned Quality and/ or Laboratory Systems in an effective and compliant manner. **About the Role**: **Key Responsibilities**: - Provides technical and/ or administrative support to the Quality...
-
Qc Specialist
3 days ago
Tuas, Singapore NUSANTARA PRIME CONSULTING PTE LTD Full time**Responsibilities**: - Support equipment, critical reagent and method transfer related qualification activities - Support setting up and maintenance of cell lines used for bioassays and support method - Participate in bioassay/QC related routine and non-routine activities according to Standard Operating Procedures such as product sample testing to meet...
-
Senior Qc Chemist
1 week ago
Tuas, Singapore Pfizer Full timePfizer Singapore is recruiting permanent employees for manufacturing site expansion of PFIZER ASIA MANUFACTURING PTE LTD (PAMPL) in Singapore. Why Patients Need You Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality...
-
Senior Qc Chemist
2 weeks ago
Tuas, Singapore Pfizer Full timeThe incumbent is a member of the Quality Control (QC) Laboratory team. Reporting to the QC Systems Manager / QC Supervisor, the incumbent will be responsible for systems related aspects supporting analytical testing in QC. These includes: - Management of the system life cycle of QC laboratory equipment from purchasing, qualification, calibration &...
-
Qc Specialist Ii
1 week ago
Tuas, Singapore Novartis Full time**Summary**: This role utilizes chemistry laboratory skills to test and measure product or raw materials while ensuring that analysis is performed according to established Standard Operating Procedures (SOPs), Analytical Methods & current Compendia **About the Role**: **Key Responsibilities**: - Sample storage and management -Analytical...
-
Specialist 1, Sample Management, QC
1 week ago
Tuas, Singapore Lonza Full time $60,000 - $80,000 per yearToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...