Glenmark Pharmaceuticals Inc.
Allentown, PA, USA
POSITION DESCRIPTION
Role / Position Title - Quality Assurance Manager
Department/Function - Quality
Country - USA
Region / City (within Country) - Allentown, PA
FLSA (Exempt/Non-Exempt) - Exempt
Hours - 8 a.m. to 5 p.m. in office 5 days per week
OVERALL JOB RESPONSIBILITIES
Note: These statements are not intended to be an exhaustive list of all responsibilities and duties.
Handling QMS (Quality Management System) activities which includes:
Handling of Deviations, Investigations, CAPA, Change Controls
Preparing and reviewing SOPs related to Quality Assurance
Reviewing SOPs related to other departments
Ensuring proper documentation control activities are being followed per cGMP requirements
Coordinating with manufacturing sites in regards to QMS activities
Review and maintaining existing Quality System and ensuring compliance to Agency Regulations / cGMP expectations
Handling employee training and ensure training is carried out...