Under the general direction of the of the Manager, he/she performs all functions associated with the day to day activities of the Quality Assurance, ES & H, and Regulatory functions within China.

The overall function of this position is to minimize the possible financial risk to PHT from claims for product quality, protect PHT International from fines assessed with non-compliance with China and non-China regulations regarding the manufacture, transportation, and distribution of chemical compounds.

The Senior Specialist supports the activities of the Sales and Marketing, and Logistics departments by participation in internal and customer audits, verifying various manufacturer permits, and completion of requested customs documentation.

This position represents QA Department to customers through various types of correspondence, questionnaires, and site visits, follows on customer complaints, and the preparation and completion of CAPA plans as needed post–audit. This position also acts as a resource to China colleagues in all aspects of QA, ES&H, and Regulatory compliance.

An additional function is the support of PHT’s cGMP manufacturing facility for quality and regulatory needs.

Strategic Objectives:

As outlined yearly by PHT International Executive Committee

Position Requirements:

1. Education and Experience

• Minimum of a Bachelor’s Degree (Master’s Degree preferred) in Chemistry or related science/ engineering discipline.

• Must be fluent in English both written and verbal.

• Prior in-depth chemical experience in a laboratory or manufacturing setting or similar. This is usually accomplished with a minimum of 5-7 years in one or both departments. Examples include R and D, Analytical, Quality, Engineering, Process Development, Operations.

• Must understand Chemical Operation Regulations and changes in product permitting in China.

• Must possess a working knowledge in US FDA and European EMA regulations.

• Excellent analytical skills

• Competence in Microsoft Office products

• Working knowledge of cGMP requirements, including validation preparation, data integrity and associated regulations.

• Excellent communication skills to work with multinational customers and colleagues

2. Personal Attributes

• Ability to train and evaluate staff performance

• Exceptionally self-motivated

• Can do attitude

• Ability to be effective with all levels of the organizations

• Willing to accept project responsibility and ownership

• Ability to perform job while traveling up to 50% of time

• Excellent time management skills

• Excellent organizational skills

• Excellent communication skills in both oral and written English

• Ability to set and manage priorities

3. Work Conditions:

• Availability for after-hours work will be required

• Must be able to follow all safety initiatives of independent chemical plants

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