Qc Specialist Ii

3 days 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**:
**QC Specialist II**

**About the Role**:
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.

**Key Responsibilities**:

- Establish and maintain QC Biochemistry lab in full cGMP-compliance.
- Review and validate product testing results and analysis under cGMP and meet required timelines.
- Provides technical support to run and validate necessary test methods on lab equipment and resolve day to day lab operations including troubleshooting of lab equipment and processes.
- Coordinate and implement short to mid-term projects by collaborating with other functions to achieve team goals. Reviewing and Approving method transfer/validation protocols and reports
- Monitoring and optimization of workflows and methods/procedures, drug substance control, method controls and reference’s and perform trending of on-going in process control data to pursue an on-going quality assurance program
- Review/Approve all lab related QA/QC documents to ensure completeness, accuracy, consistency, and clarity and that materials or final products have been manufactured, tested, or inspected according to specification and cGMPs.
- Recommend and execute improvements to current processes or systems including creating new test procedures to deliver set KPIs.
- Prepare and participate in health authorities’ inspections and internal audits in respective area. Support and supervise team on day-to-day lab operations as and when required.

**Essential Requirements**:

- 5+ years of relevant industry experience, preferably in a cGMP environment
- Hands on experiences in cell-based bioassay, ELISA (Enzyme-linked Immunosorbent Assay), PCR (Polymerase Chain Reaction)
- cGMP knowledge and understanding of manufacturing, quality control, and validation requirements and activities will be advantageous.

Division

Operations

Business Unit

Pharmaceuticals

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.

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