Packaging Quality Manager

Vor 7 Tagen


Geneve, Schweiz Modis Vollzeit

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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