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

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