We are recruiting, on behalf of our client, a Packaging Quality Manager, on a permanent position.
At this role, you will be in charge of batch-record for the packaging on site and at sub-contractor’s site. You will also maintain and improve the quality system at the local level.
· Review batch records (production and packaging)
· Review of Syringes sub-contractor batch
Improve, maintain and assure a continuous improvement of the following local Quality Systems to assure the quality of the product:
· QA oversight of packaging and production area
· Manage deviations related to packaging area and participate to investigations related to production and QC with the concerned functions
· Follow up of PQI (Potential Quality Incident),
· Participate in complaints investigation and Trackwise approval
· Review/approve for issuance of GMP documents related to packaging area (SOP’s, specifications, protocols, reports..)
· Review and approve validation/qualification documentation related to packaging area
· Ensure that activities related to the quality in packaging are conform with the company policies and Corporate Quality directives
· Participate in Risk analysis in collaboration with supportive department.
· Manage templates/specifications in LIMS and assure their update
· Establish compilations and trending of GMP data
· Auditor in self-inspections and external audits
· Participate as QA representative to projects related to packaging area.
· Manage for her/his responsibility area regulatory inspection
· Perform audit trail review of GMP systems.
· Evaluate any signal detection which could have a potential product quality impact
· Diligently report to head of Quality Unit any Quality Alert/issue and actively participate to resolve significant Quality issues when they arise
· Assure a communication flow and collaboration with Operations and other functions to assure a product life-cycle quality
· Indirect management of investigation teams and risk analysis team
· Backup in production deviation management and complaints management
· Bachelor, University degree in Chemistry, or Master’s degree in Quality Assurance, Quality Control and Validation Method
· At least 4 years of experience in QA environment pharmaceutical industry
· Fluency in English (both oral and written)
· Extremely motivated, with rigorous work habits and problem-solving skills
· Quality commitment, flexibility, initiative, cross functional cooperation behavior
· Excellent team player with a strong ability to communicate