The incumbents’ primary responsibilities include the monitoring and maintenance of the cGMP requirements.  Other duties will include the continued review and preparation of technical and compliance documentation.

 

Essential Job Duties:

   Prepare and review of SOPs and other quality assurance related  technical data forms

·        Proper maintenance of control documents in Quality Assurance

·        Issuance of controlled documents to different departments

·        Review and verify raw materials, solvents and intermediate dispensing activities.

·        Issue change control number

·        Prepare and reconcile Finished product  labels

·        Perform audits of the quality control raw data related to raw materials, solvents and intermediate release

·        Audit stability  raw data generated in the Quality Control Department

·        Issue batch records to manufacturing department as required

·        Review of executed batch records

·        Line clearance and  Online checking of production activities

·        Monitor sampling of intermediates and cleaning samples

·        Periodic review of equipment usage logs of QC and Manufacturing, QC lab chemicals and reagents, housekeeping usage logs

·        Prepare annual product reviews

·        Review of instrumentation calibration records

·        Assist in carrying out internal quality audits on company systems and documentation

·        All other related duties as required and assigned by the reporting Manager

 

Experience & Education:Bachelor’s degree required in a scientific or related field. 

 

Knowledge:Possesses extensive knowledge of cGMPs. Knowledgeable in SOP writing. Understanding of product  manufacturing processes. Working knowledge of structured product labeling.

 

Skills & Abilities:

·        Ability to work independently with little to no supervision

·        Exceptional oral and written communication capabilities

·        Advanced computer knowledge in MS Office programs

·        Excellent organizational abilities and superior attention to detail

·        Must have high level of interpersonal skills

·        Ability to maintain high level of confidentiality at all times

·        Possesses strong analytical and problem solving skills

·        Excellent time management skills and project management skills

 

Working Conditions:Position will be mainly office based and clerical in nature. Incumbent will be working in a laboratory and manufacturing facility and will be exposed to these environments. Minimal travel required