Purpose: Ensure GMP compliance in API Production areas

Responsibilities and Duties

Review Batch Records directly during production phases

Serve as liaison to production operators and shift leaders to provide support and guidance to ensure GMP compliance

Communicate with Facility Maintenance team members to understand the control of the production environment during specific events that may impact the quality outcome of API

Participate in the initiation or completion of deviations investigations and risk assessments for product quality events to include conducting root cause analysis and performing interviews with appropriate employees

Collaborate in the drafting / revision of SOP and MBR, verify correct GMP application and alignment of performed operations with written instructions

Review all GMP documentation related to the production area

Evaluate change proposals and implementation

Verify process documentation

Ensure continuous auditing of production areas

Oversee correct application of equipment cleaning procedures

Review process validation, cleaning validation and equipment / facility qualification protocols

Report critical quality situations to supervisors, evaluate solutions and implement directives

Propose and monitor implementation and effectiveness of CAPAs related to area of responsibility

Support client audits both during on site visits and during drafting of CAPA Plans

Required Qualifications

Must have direct experience with Quality Assurance within an regulated industry (USDA, FDA, ISO etc)

Understands and applies comprehensive knowledge of quality and GMP principles and maintains current understanding of global GMP drug manufacturing regulations

BA/BS degree in Science related field or manufacturing is highly preferred, however, strong experience in Quality Assurance in a regulated industry may be considered in absence of a 4 year degree

5 plus years experience as a Quality Professional required