Summary

Job Context

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Job Responsibilities

Provide leadership and direction to group to ensure achievement of CMC Quality accountabilities and responsibilities.

To provide guidance for robust analytical method development to ensure decrease in method failures.

To support on pharmacopoeia updates and new regulations for analytical methods to ensure continual improvement of the quality system.

To lead, manage and motivate people with a variety of skill sets. Strong organizational, interpersonal and communication skills are essential. Use excellent negotiation and interpersonal skills to communicate effectively with all levels of the organization and external stakeholders.

To ensure the complaint of Analytical Method Development activities related to Chemical Entities, API, Drug Product Formulations.

To assure that Method Validation / Method Qualification / Method Transfer data are reviewed adequately within time and verify scientific rigor, adequacy, and completeness. Take active participation in the trouble shooting.

Developing procedures / system to ensure compliance of R&D function.

To provide technical support for Plant Analytical Trouble Shooting investigation and regulatory query response.

Expertise in Quality Risk Management Method & Tools (Like Failure Mode Effects Analysis (FMEA), Fault Tree Analysis (FTA), Heatmap, Fishbone etc).

Expertise in extractable and leachable study.

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Experience Requirements

• 1 - 3 years

Educational Requirements

• Masters

Skills

• est

Age

• 23 - 35 Age

Additional Requirements

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Compensation & Other Benefits

• - Tour , Medical , Holidays , Performance Bonus
• - Salary Review: Half Yearly

Work place

• Work At Office

Employment Status

• Full Time

Gender

• Male

Job Location

• Taiwan