Reviewer, Documentation ARD (Contract)

Job purpose

The main purpose of this position is to:

Duties and responsibilities

• Planning and prioritizing assigned document review workload to meet the required lead times and due dates for CMC submissions.
• Ensure that all laboratory related documents for incoming goods, raw material, bulk, finished products, stability, calibration and analytical development and method validation are reviewed to meet Taro and cGMP requirements per assigned timelines and objectives.
• Review accuracy of data in Stability Application Software and Empower Software
• Review OOT/OOS investigations and assist in establishing the root cause
• Create, review and write SOPs pertaining to the group.
• Review current systems and procedures and implement changes where appropriate to improve accuracy and throughput
• Complete all GMP Documentation correctly and in a timely manner
• Complete all training assignments and maintain personal training
• Complete Corrective and Preventive Actions (CAPA's) as assigned
• Initiate, and follow through with actions required to close Change Controls
• Other duties as assigned

Qualifications

• Minimum of B.Sc. Chemistry
• About 5 years’ experience as an analyst in the pharmaceutical industry
• Minimum 1-year experience reviewing R&D documentation
• Thorough knowledge of R&D pharmaceutical and laboratory operations
• Thorough knowledge of cGMP, GLP, FDA, TPP, HPLC, wet chemistry and/or microbiology functions
• Established record of quality work while performing Hands On activities (if applicable)
• Knowledge of analytical method validation.
• Knowledge of applicable software
• Ability to influence others to do things while maintaining integrity and trust, by keeping a continuous focus on effective communications to ensure achievement of shared goals.
• Excellent written communication and report writing skills
• Effective organizational skills and ability to multi-task; detail oriented with ability to effectively close task and make decisions/recommendations as required.
• Problems associated with the supervision of any department (staffing, out-of-stock, procedures/practices, review of Out of Spec results)

Working conditions

Generally, fairly pleasant surroundings. Occasional exposure to higher than normal noise levels, exposure to various chemicals used in the testing of raw materials, components and finished products. Occasional exposure to unpleasant odors resulting from testing procedures. Fairly level temperatures, etc.

Physical requirements

N/A

Direct reports

N/A