Qc Analyst Ii

5 days ago

Tuas, Singapore Novartis Full time

**Summary**:
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.

**About the Role**:
Position Title: QC Analyst II
- Location - Singapore
- 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

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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