Job purpose
The main purpose of this position is to:
Ensure that the reviewed documentation of all R&D lab functions reflects that these are in compliance with cGMP and meet all approved procedures.
All review work is done in effective manner and per plan.
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 records
Complete Corrective and Preventive Actions (CAPAs) 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
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
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