Assistant Manager/Senior Chemist Analytical Technical Service

Xepa-Soul Pattinson (Malaysia) Sdn Bhd

Malacca

Job Location: Cheng, Melaka, Malaysia

Duties and Responsibilities:
• To lead the key focus areas (stated above) as designated, in terms of analytical activities planning and scheduling, and cross-functional communication.
• To lead Analytical method development & validation for new raw material, packaging, and product (NPD) for both in-house developed or technical transfer, reformulation, and cleaning validation.
• To lead analytical method development of new parameters and improvements for commercialized products.
• To lead impurity analysis to fulfill ICH M7 and ICH Q3 requirements.
• To lead method validation and verification, with complete documentation, following ICH Q2 requirements.
• To lead analytical method transfer to and out of Quality Control.
• To lead investigation reports for Out-of-Specification and Out-of-Trend analytical results (including equipment troubleshooting), and support regulatory correspondence to support the company in any regulatory correspondence with... More Detail

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