Qureos Mentor

<div>
 
 
 Overview of this Position:
 
 The
 
 Quality Assurance Manager
 
 leads quality oversight for sterile manufacturing operations, ensuring full compliance with FDA regulations, EU GMP, and Annex 1 requirements. This role is responsible for batch record review and lot release, as well as driving robust deviation investigations and CAPA management to maintain product sterility assurance and regulatory compliance. The QA Manager partners closely with manufacturing, quality control, and engineering teams to support efficient production while upholding the highest standards of aseptic processing and contamination control in a dynamic, growth-oriented environment.
 
 
 
 
 
 
 Non-Negotiable Requirements:
 
 
 
 &bull; Bachelor&rsquo;s degree in biology or related field
 
 
 &bull; Strong working knowledge of FDA regulations, EU GMP, and Annex 1
 
 
 &bull;Proven working experience in lot release, deviation management, and CAPA systems
 
 
 &bull;Experience supporting regulatory inspections and audits (FDA/Client)
 
 
 &bull;Excellent problem-solving, communication, and leadership skills.
 
 
 
 
 
 
 
 
 
 Preferred Requirements:
 
 
 
 &bull;Experience with electronic quality management systems (eQMS).
 
 
 &bull;Strong understanding of risk management principles (e.g., ICH Q9).
 
 
 &bull;Ability to manage multiple priorities in a fast-paced environment.
 
 
 
 
 
 
 
 
 
 Responsibilities Include:
 
 
 
 &bull; Ensure operations are conducted in accordance with applicable
 
 FDA regulations, EU GMP requirements, and Annex 1 guidance
 
 for both sterile and non‑sterile manufacturing activities
 
 
 &bull;Review batch records and supporting documentation
 
 in accordance with approved procedures
 
 to ensure product quality and data integrity prior to disposition
 
 
 &bull;Lead and support
 
 deviation investigations
 
 , including documentation of root cause analysis and implementation of timely, compliant resolutions
 
 
 &bull;Develop, implement, and track
 
 Corrective and Preventive Actions (CAPAs)
 
 in alignment with quality system requirements to mitigate recurrence of identified issues
 
 
 &bull;Review and approve
 
 SOPs, protocols, and validation documentation
 
 related to sterilization processes, aseptic filling, cleaning, and gowning practices
 
 
 &bull;Ensure
 
 personnel qualification and training requirements
 
 for aseptic operations&mdash; including media fills and gowning qualifications&mdash;are maintained, current, and effective
 
 
 &bull;Support internal and external audits, including
 
 regulatory inspections
 
 , and maintain a state of audit readiness; serve as a
 
 subject matter expert
 
 for sterile manufacturing and Annex 1 compliance when required
 
 
 &bull;Partner with Manufacturing, Quality Control, and Regulatory Affairs to ensure
 
 alignment on quality standards, expectations, and regulatory commitments
 
 
 
 &bull;Monitor quality metrics and performance indicators to identify trends and support
 
 continuous improvement initiatives
 
 
 
 &bull;Provide guidance and training to QA personnel and cross‑functional teams on
 
 quality systems, compliance expectations, and best practices,
 
 support departmental operations and staff development
 
 
 
 
 
 
 
 
 
 The duties listed above are intended to describe the essential functions of this position. Additional responsibilities may be assigned as needed. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this job. This role may require sitting, standing, or walking for extended periods, using a computer, and working in a standard office environment. Specific physical or environmental requirements will be addressed through the reasonable accommodation process. We do not discriminate based on disability and will provide reasonable accommodation as required by law.
 
 
 
 
</div>

Quality Assurance Manager

Join ZRG and explore 1   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

ZRG

About Company

Quality Assurance Manager