Packaging Quality Manager - Permanent position

Packaging Quality Manager - Permanent position

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.

Responsibilities:

Batch review

· 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.

 

Communication

· 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

 

Management

· Indirect management of investigation teams and risk analysis team

 

Backup

· Backup in production deviation management and complaints management

Profile:

· 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