Qc Analyst Ii

1 week ago

Singapore Novartis Full time

394094BR

**QC Analyst II**:
Singapore

**About the role**

Location - Singapore #LI Hybrid
About the Role:
This role will 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.
Key Responsibilities:

- Perform product testing and analysis under cGMP to meet required timelines.
- Provide technical support to run and validate necessary test methods on lab equipment and in developing method transfer/validation protocols and reports.
- Support lab equipment qualification and improvement projects
- 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.
- Prepare and participate in health authorities 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.
- Able to support rotating shift hours (Day/night).

**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._

**Role Requirements**

Essential Requirements:

- Delivery of results in time and quality (e.g. review and approve validation, qualification protocols and reports)
- Adherence to established KPI targets related to QC activities (global and local)
- Project progressing according to plan and quality expectations.
- Number and severity of cGMP issues identified during internal and external audits
- No critical observations during authority inspections
- No delay with new product introductions caused by the lab

Desirable Requirements:

- University degree with a scientific / technological background (e.g. Chemistry, Pharmacy, Biology, Biochemistry, or equivalent)


**Division**

Operations

**Business Unit**

QUALITY

**Work Location**

Singapore

**Company/Legal Entity**

NOV SINGAPORE PHARMA MANUFG

**Functional Area**

Quality

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

Yes

**Early Talent**

No

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