Qureos Mentor

Pharco Corporation

<div>
 
 
 Position Overview:
 
 
 
 We are seeking an experienced and dynamic Quality Assurance (QA) Manager to lead our QA operations at
 
 AMRIYA
 
 manufacturing facility. The ideal candidate will have a robust background in sterile pharmaceutical manufacturing and a deep understanding of GMP regulations.
 
 
 
 Key Responsibilities
 
 
 <ul>
 <li>
 Lead and manage the
 
 Quality Assurance department
 
 , ensuring full compliance with
 
 GMP standards
 
 and regulatory requirements.
 </li>
 <li>
 Design, implement, and sustain
 
 quality systems and procedures
 
 for both sterile and non-sterile manufacturing operations.
 </li>
 <li>
 Oversee
 
 site QA activities
 
 with a focus on
 
 audit readiness
 
 and continued
 
 cGMP compliance
 
 .
 </li>
 <li>
 Direct the
 
 investigation of deviations
 
 ,
 
 CAPAs
 
 , and
 
 OOS incidents
 
 related to GxP activities.
 </li>
 <li>
 Monitor and verify the compliance of
 
 utilities, water systems, and environmental conditions
 
 in accordance with quality standards.
 </li>
 <li>
 Conduct
 
 risk assessments
 
 , identifying potential issues through
 
 root cause analysis
 
 and implementing
 
 preventive actions
 
 .
 </li>
 <li>
 Manage validation and compliance efforts to ensure
 
 consistent product quality
 
 and adherence to specifications.
 </li>
 <li>
 Serve as the point of contact for
 
 regulatory communications
 
 and coordinate responses with internal stakeholders.
 </li>
 <li>
 Collaborate cross-functionally to
 
 drive process improvements
 
 and maintain high-quality standards.
 </li>
 <li>
 
 Coach, train, and mentor
 
 QA personnel, fostering a culture of
 
 continuous improvement
 
 and
 
 quality excellence
 
 .
 </li>
 </ul>
 
 
 Qualifications
 
 
 <ul>
 <li>
 Bachelor&rsquo;s or Master&rsquo;s degree in
 
 Pharmacy or Science
 
 .
 </li>
 <li>
 At least
 
 10 years of experience in Quality Assurance
 
 , with a strong background in
 
 sterile pharmaceutical manufacturing
 
 .
 </li>
 <li>
 Minimum
 
 3 years of experience in a leadership or managerial role
 
 within QA.
 </li>
 <li>
 Familiarity with
 
 global regulatory agencies
 
 and compliance requirements.
 </li>
 <li>
 Demonstrated
 
 leadership capabilities
 
 , with a track record of managing high-performing QA teams.
 </li>
 <li>
 Excellent
 
 communication
 
 ,
 
 analytical
 
 , and
 
 problem-solving
 
 skills.
 </li>
 <li>
 Detail-oriented and
 
 highly organized
 
 , with the ability to manage multiple priorities efficiently.
 </li>
 </ul>
 
 
</div>

Quality Assurance Manager

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Pharco Corporation

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Quality Assurance Manager