Company:  Confidential

Job Title: QA Engineer

Job Number: 77882

Location: Petersburg, US

Job Description

Key responsibilities of this role include overseeing quality systems to ensure that the validation/qualification and operation of processes, facilities, equipment, and computer systems meet cGMP and compliance standards. This oversight begins with the facility’s startup and continues until successful approval by the FDA, including the ongoing introduction and approval of new medications. Additionally, the role involves tasks such as generating, reviewing, and/or approving policies, procedures, reports, and other documentation essential for quality assurance. This includes validation, qualification, and ongoing operational activities related to facility, utilities, processes, equipment, and instrumentation, all aimed at ensuring compliance with FDA requirements.

Responsibilities

* Collaborate across departments to ensure that the site’s quality system processes align with GMP standards for facility, equipment, computer systems, and procedures. * Partner with validation and engineering teams to oversee quality during validation and qualification activities, ensuring compliance and control throughout. * Stay updated on local and international regulatory requirements and trends, offering expert advice and technical support on quality matters to the site. * Work cross-functionally to develop and implement processes effectively. * Ensure compliance during product and process transfers between manufacturing sites, including validation. * Provide support for overall facility, equipment, and manufacturing process compliance. * Support quality processes throughout the product lifecycle, including change control, CAPA, deviations, laboratory controls, product quality complaints, APQR, and management notifications. * Review and support calibration and maintenance programs to ensure GMP compliance and adherence to site procedures. * Lead or participate in deviation investigations and quality risk analyses. * Proactively identify and resolve problems using functional and technical expertise, prioritizing risk-based and compliant approaches. * Advocate for a quality-focused approach in all activities and operations. * Prioritize safety in all operations and activities. * Some travel (up to 10%) may be necessary.

Required Skills

* A Bachelor’s degree in a scientific field with at least 7 years of experience in Quality/cGMP within the pharmaceutical sector. * Proficiency in facility and equipment qualification, process validation, computer system validation, as well as calibration and maintenance programs. * Familiarity with 21CFR Part 11, Electronic Records and Signatures, and a solid understanding of data integrity principles. * Strong project management skills, organizational abilities, and a knack for executing tasks efficiently, capable of handling multiple projects and priorities simultaneously. * Involvement in and leadership of activities to support regulatory agency inspections. * Self-driven, adaptable, and comfortable working in a small, fast-paced, and dynamic environment. * Ability to work independently while adhering to established guidelines, procedures, and practices. * Acting as a Quality subject matter expert to facilitate thorough investigations to determine root causes. * Leveraging personal experience and industry best practices to enhance continuous improvement of site procedures. * Committed to delivering high-quality outcomes, collaborating with others to overcome obstacles, and concentrating on essential priorities. * Actively seeking opportunities for learning, skill development, and knowledge sharing with colleagues. * Exceptional interpersonal and written communication skills, along with proficiency in various software and electronic applications. * Experience spanning the product development and commercialization lifecycle. * Technical proficiency in sterile pharmaceuticals.

Application Deadline: 2024-06-03

 

Apply for job

To apply for this job please visit jobrxiv.org.