Plant QA Manager 24/7

<h2><b>Career Category</b></h2>Quality<h2></h2><h2><b>Job Description</b></h2><p>Plant QA Manager Responsibilities<br />• Responsible for leading and directing a team on 24/7 shift including managing their performance and supporting their development.<br />• Provide real-time QA oversight and support for production operations. This currently extends to formulation, vial and Syringe Fill Finish aseptic operations and visual inspection.<br />• Collaborate with operations to resolve quality and compliance issues, including but not limited to Change Controls, NCs and CAPAs.<br />• Ensures that changes that could potentially impact product quality are assessed according to procedures (ex: site change control, maximo)<br />• Review and approve cGMP records (e.g., Non Conformances, CAPA’s, electronic batch record, change controls, design qualifications, SOP, etc.) ensuring compliance with appropriate documentation<br />• Alerts senior management of quality, compliance, supply and safety risks<br />• Support and represent Quality during audits and inspections<br />• Support Lean Transformation and Operational Excellence initiatives<br />• Provides training and advice to staff in order for them to perform their desired functions.</p><p>The knowledge and skills necessary to perform the duties of the QA Manager are typically acquired through the following combination of education, experience and knowledge. <br /> </p><p>Basic Qualifications<br />• University degree. Engineering or Science related discipline preferred.<br />• Relevant experience (8yrs &#43;) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.<br />• Technical skills and demonstrated competencies across a broad range of quality related disciplines. <br /> <br />Preferred Qualifications<br />• Experience working in aseptic operations, protein formulation, vial and syringe filling.<br />• Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non Conformance /Deviation investigations<br />• Experience working with dynamic cross-functional teams and proven abilities in decision making<br />• Experience in management or leadership roles<br />• Detailed Knowledge of applicable Regulatory requirements.  Experience with Regulatory inspections.<br />• Excellent written and verbal communication skills<br />• Strong organizational skills, including ability to follow assignments through to completion</p><p></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p>.