Reviewer

Profile Summary

We are looking out for a QC Reviewer who can manage, organize, coordinate and control the Laboratory Documentation review to attain the most effective and efficient deployment of human and material resources. This must be achieved through efficiency both in time and material resources, while ensuring compliance with company procedures.

Expected Qualification

A Bachelor’s or Master’s degree in chemistry.

Expected number of Years of Experience

5 – 8 years

Roles and Responsibilities

• To audit all laboratory worksheets, calibration protocols/reports and raw data archives to ensure the validity and accuracy of the data.
• To prepare and check Certificates of Analysis for all lots of raw materials and packaging materials tested in the QC Department.
• To provide training and retraining to new or existing laboratory staff on proper laboratory documentation procedures as required and ensure that this is documented according to procedures.
• To coordinate review in order to ensure that all materials are reviewed and released in a timely manner to meet production schedules.
• To act as backup on any archival and sample registration processes when required.
• To ensure GMP compliance as per local procedures, and GLP guidelines.
• Current Good Manufacturing Practices (cGMP), Good laboratory practices (cGLP), FDA guidelines, and other regulatory requirements.
• Prepares or reviews the calculation of control limits, detection limits, and reporting limits for laboratory analyses.
• Evaluates new analytical methods and instrumentation for use by District staff; provides
• Makes recommendations for in-house testing or outsourcing of laboratory analyses routine
solution preparation or purchase of prepared reagents, and purchase of laboratory instrumentation.
organizations, and others on matters related to laboratory quality assurance.
• Prepares, reviews, and updates the Laboratory Chemical Hygiene Plan.
• Performs or directs internal audits of test methods to identify biases and areas for improvement.

Required Skills

• A good understanding of analytical testing and equipment operation / troubleshooting
• Knowledge and understanding of analytical methodologies and instrumentation.
• Possession of good communication, troubleshooting and function skills.
• Proactive attitude towards work and learning new techniques.
• Good time management skills.
• Good organizational skills.
• Ability to work in a team.
• Ability to communicate clearly and concisely in English, both orally and in writing
• Computer programs and applications.
• Mathematical and statistical skills.