Qc Analyst

1 week ago

Singapore Novartis Full time

QC Analyst (QC Biochemist 3)
Location - Singapore #LI Hybrid
About the Role:
Execution of assigned tasks in the quality control laboratory in accordance with cGxP regulations. Performance of laboratory specific activities such as analyses, maintenance, calibration and qualification of analytical equipment.
Key Responsibilities:

- Analytical testing and documentation of API / drug substance / drug product / finished product / Complaints / stability / packaging material samples
- Ensure proper maintenance of QC IPC/DS (In Process control/Drug Substance) lab equipment and systems and troubleshoot to ensure full cGMP-compliance for shift team.
- Provide technical support to run and validate necessary test methods such as ELISA and bioassays under cGMP requirement.
- Support in developing method transfer/validation protocols and reports
- Participate in carrying out laboratory investigations by identifying documents and information to support root causes.
- Prepares and/or review QC documents, including complex assays, to ensure completeness, accuracy, consistency, and clarity and that materials or final products have been manufactured, tested, or inspected according to specification and cGMPs.
- Suggest ideas and execute improvements to optimize test procedures or efficiency whenever possible.
- Prepare and participate in health authority’s inspections and internal audits in respective area.
- Provide on the job guidance to new job holders to carry out basic day to day lab operation works.
- Suggest ideas and execute improvements to optimize test procedures or efficiency whenever possible.

**Commitment to Diversity & Inclusion**:

- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Minimum requirements**

Essential Requirements:

- Preferred: Previous experience working in a laboratory environment in the pharmaceutical industry (quality assurance, production), aseptic technique.
- Collaboration; result-oriented
- Administrative activities and GMP and HSE-compliant, efficient production and documentation of standardized tasks in the infrastructure
- Breakthrough Analysis; Being Resilient; Operational Excellence; Continuous Learning; Digital & Tech Savvy
- Laboratory equipment; Quality Control (QC) Testing; Quality Control Sampling; knowledge of TQM and related industry GxP standards and processes; Laboratory Excellence; Quality decision making

Desirable Requirements:

- Completed apprenticeship as a laboratory assistant or equivalent training


**Division**

Operations

**Business Unit**

QUALITY

**Country**

Singapore

**Work Location**

Singapore

**Company/Legal Entity**

NOV SINGAPORE PHARMA MANUFG

**Functional Area**

Quality

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

No

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