Other

Cannerald AG

51-200

Human Resources and Payroll Administrator

Switzerland



## Tasks

*   Implement and lead Quality Assurance (QA)  
*   Contribute to a risk-based strategy for QA activities  
*   Provide QA oversight within the company and at vendor sites 
*   Review and approval of GMP relevant Documents like Plans, Reports, SOPs, Change Control, Discrepancy Management, CAPA (corrective action and preventive action), Risk Analysis 
*   Provide advice and support for the audit process to ensure a good audit practice 
*   Prepare and host regulatory inspections and partner GxP audits 
*   Plan and implement supplier and internal audits 
*   Coordinate and lead internal or external training activities 
*   Participate or lead departmental and cross-functional compliance initiatives 
*   Management of the Quality Assurance and Quality Control teams 
*   Monitor CAPAs 
*   Creation and periodic review of quality agreements (QAGs) with contract organizations  
*   Act as local expert for GxP related questions. 
*   Implement and update Technical Quality Agreements with Suppliers and Customers 
*   Conducting effective Quality Review Meetings 
*   Assistance is required in the introduction and training of new employees

**Quality Control Responsibilities:**

*   Manage QC projects from a strategical point of view 
*   Drive continuous improvement in the lab 
*   Manage deviations and investigations 
*   Enforce all safety and security policies and practices 
*   Monitor the testing techniques and the accuracy and completeness of all records and documentation 
*   Ensure that all in-process samples, raw material and final products are analyzed in accordance with SOPs and regulatory requirements to applicable GMP’s and standards. 
*   Enforce all laboratory policies and practices 
*   Ensure the calibration and maintenance of the lab instruments 
*   Initiate and support Corrective and Preventive actions in the laboratory 
*   Ensure audit readiness in laboratory, subjects preparation and presentation during audit 
*   Ensure the training of the lab analysts 
*   Supervise and participate to the validation activities of the laboratory

## Requirements

*   Graduate degree in chemistry, biology, or a related field 
*   Minimum 5 years of experience in a quality assurance or quality control management position 
*   Experience in auditing and dealing with the authorities 
*   Statistical experience, as well as experience in data integrity 
*   In-depth knowledge of GxP 
*   Experience in laboratory management (preferred) 
*   Formal training in quality assurance and GMP guidelines (preferred) 
*   Fluency in German and English

Employee

<h2 id="tasks">Tasks</h2>
<ul>
<li>Implement and lead Quality Assurance (QA)  </li>
<li>Contribute to a risk-based strategy for QA activities  </li>
<li>Provide QA oversight within the company and at vendor sites </li>
<li>Review and approval of GMP relevant Documents like Plans, Reports, SOPs, Change Control, Discrepancy Management, CAPA (corrective action and preventive action), Risk Analysis </li>
<li>Provide advice and support for the audit process to ensure a good audit practice </li>
<li>Prepare and host regulatory inspections and partner GxP audits </li>
<li>Plan and implement supplier and internal audits </li>
<li>Coordinate and lead internal or external training activities </li>
<li>Participate or lead departmental and cross-functional compliance initiatives </li>
<li>Management of the Quality Assurance and Quality Control teams </li>
<li>Monitor CAPAs </li>
<li>Creation and periodic review of quality agreements (QAGs) with contract organizations  </li>
<li>Act as local expert for GxP related questions. </li>
<li>Implement and update Technical Quality Agreements with Suppliers and Customers </li>
<li>Conducting effective Quality Review Meetings </li>
<li>Assistance is required in the introduction and training of new employees</li>
</ul>
<p><strong>Quality Control Responsibilities:</strong></p>
<ul>
<li>Manage QC projects from a strategical point of view </li>
<li>Drive continuous improvement in the lab </li>
<li>Manage deviations and investigations </li>
<li>Enforce all safety and security policies and practices </li>
<li>Monitor the testing techniques and the accuracy and completeness of all records and documentation </li>
<li>Ensure that all in-process samples, raw material and final products are analyzed in accordance with SOPs and regulatory requirements to applicable GMP’s and standards. </li>
<li>Enforce all laboratory policies and practices </li>
<li>Ensure the calibration and maintenance of the lab instruments </li>
<li>Initiate and support Corrective and Preventive actions in the laboratory </li>
<li>Ensure audit readiness in laboratory, subjects preparation and presentation during audit </li>
<li>Ensure the training of the lab analysts </li>
<li>Supervise and participate to the validation activities of the laboratory</li>
</ul>
<h2 id="requirements">Requirements</h2>
<ul>
<li>Graduate degree in chemistry, biology, or a related field </li>
<li>Minimum 5 years of experience in a quality assurance or quality control management position </li>
<li>Experience in auditing and dealing with the authorities </li>
<li>Statistical experience, as well as experience in data integrity </li>
<li>In-depth knowledge of GxP </li>
<li>Experience in laboratory management (preferred) </li>
<li>Formal training in quality assurance and GMP guidelines (preferred) </li>
<li>Fluency in German and English</li>
</ul>


Head of Quality

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