To perform QC test as required. Supervising the review of laboratory data (both internal and external) and the closeout of deviations. Author and review Change Controls, Deviations/Investigation as well as Test Methods, Specifications and SOPs.

Duties and Responsibilities:

• To perform QC test as required.
• Supervising the review of laboratory data (both internal and external) and the closeout of deviations
• Author and review Change Controls, Deviations/Investigation as well as Test Methods, Specifications and SOPs
• Perform report writing (Example: Deviations/Investigations/Trending)
• Maintains knowledge of new technologies
• Strong ability to manage multiple priorities and lead projects.
• Source of expertise for rest of staff
• Customer and regulatory agency interaction as required
• Problem solving of analytical/ microbiological methods as well as troubleshooting of equipment as applicable.
• Manage/perform equipment qualification and validation maintenance review
• Lead/ execute method transfers and validation/ qualification

  Specifically,

• Technology and techniques of focus area: UV, Infrared Spectroscopy, Osmolality, HPLC, pH, Conductivity, Polarimetry, Refractometer, Density meter, Titration (manual and automatic), as well as all compendial testing listed in the USP, JP and EP monographs.
• Any other duties as assigned by your Manager

Education / Experience

• Relevant experience and accomplishment to dictate final position for which the candidate may qualify
• Good problem solving and analytical skills
• Good communication skills
• Decision Making
• Planning/Organizing
• Effective Communication
• Personal Orientation
• Teamwork
  

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