Senior Quality Assurance Manager

<p>Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.</p><p><br/>We are PCI. </p><p><br/>Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.</p><p>   </p><p>Main purpose of job: </p><p>The role is to lead the Quality Assurance Team to implement and execute tasks relating to day-to-day Quality Assurance aspects, but also executing those tasks him/herself.  The role entails taking responsibility for Quality Assurance matters around processes and documentation and for the team.</p><p></p><p>Main responsibilities:</p><ul><li>Leads and develops the Quality Assurance team as well; leads continuous improvement of processes and workflows within the team</li><li>Writes and reviews SOP's, Work Instructions and Forms.</li><li>Coordinates and reviews Deviations, Non-Conformance reports, Corrective and Preventive Action Requests and assists in the preparation of final reports for QP review.</li><li>Coordinates the Change Control Board, follows up on change control actions with appropriate action owners and drives for on time closure of actions.</li><li>Prepares Metrics.</li><li>Completes complaints investigations and assists with close-out of complaints.</li><li>Responsible for training for quality &amp; other relevant personnel.</li><li>Represents PCI in client calls and meetings</li><li>Overall responsible for qualification and validation tasks</li><li>Coordinates cGMP internal audits.</li><li>Coordinates and assists in the performance of external audits (as required).</li><li>Assists with preparation for client/regulatory audits.</li><li>Assists with audit requests during client/regulatory audits.</li><li>Prepares responses to client audits.</li><li>Hosts/attends cross-departmental meetings as required as quality representation.</li><li>Identifies and supports opportunities for improving processes and or procedures.</li><li>Leads specific or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder’s capabilities.</li></ul><p></p><p>Specification:</p><ul><li>At least 5 Years’ Experience within a quality systems related role, preferably as a manger</li><li>Demonstrable experience within Quality department in a packaging or pharmaceutical company. </li><li>High level knowledge of packaging equipment, facilities, and processes.</li><li>To have good knowledge of Quality Assurance inspection requirements.</li><li>Good working knowledge of cGMP</li><li>QMS Experience</li><li>Risk Analysis and Associated Methodology</li><li>Knowledge of ICH, GAMPs, Annex 11 and Eurdalex guidelines</li><li>Formally qualified to Degree level in an Engineering or other scientific discipline</li><li>Received formal training in cGMP requirements from Quality Assurance</li><li>Fluent in business German and English</li></ul><p></p><p></p><p>Join us and be part of building the bridge between life changing therapies and patients. <a href="https://pci.com/" rel="noopener noreferrer" target="_blank">Let’s talk future</a></p><p></p><p>Equal Employment Opportunity (EEO) Statement:<br/>PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.</p>