QC Specialist II (Microbiology)

Singapore
Permanent
Full-time

17 days ago

Job Description Summary Establish and ensure testing of drug substance release and stability testing including all testing of intermediates in process. Control samples and lab operations are in accordance with written testing SOP’s and local/international regulations.Job DescriptionKey Responsibilities:

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)
Comply with all HSE guidelines
Detect and report potential accident, risks and propose solutions
Participate in HSE risk assessments
Preparation and participation to internal HSE audits
Responsible for participating in initial training and retraining

Essential Requirement:

Professional experience (6+ years) in the pharmaceutical sector or in the manufacture of active substances in analytical laboratories in a GMP environment or equivalent; Collaborating across boundaries; Functional Breadth; efficient inter and intra-departmental communications.
Collaboration; result oriented. Breakthrough Analysis; Being Resilient; Operational Excellence; Continuous Learning; Digital & Tech Savvy
MS Office applications and other standard IT applications supporting Quality activities
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 Requirement:

Technical education & 3-5 years relevant experience or University degree in Microbiology, Biochemistry or equivalent + 0-4 years working experience.

Skills Desired Continued Learning, Dealing With Ambiguity, Decision Making Skills, Gxp, Industry Standards, Laboratory Equipment, Laboratory Excellence, Quality Control (Qc) Testing, Quality Control Sampling, Self-Awareness, Technological Expertise, Total Quality Management

Novartis

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