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The Quality Engineer will join the Quality organization at the manufacturing site by bringing their knowledge and experience in service to patients and pursuit of excellence in quality and compliance. This site serves as a new fill finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications.
Responsibilities of the position include maintaining quality systems and oversight to ensure the validation/qualification and operation of process, facility, equipment, and computer systems meet cGMP and company’s compliance requirements at the onset of building the facility leading to successful U.S. Food and Drug Administration (FDA) approval of the facility and the ongoing introduction and approval of new medications.
Responsibilities also include, but are not limited to, the generation, review and/or approval of policies, procedures, reports, and other records necessary to provide quality oversight of team’s Engineering functions including validation, qualification and ongoing operation activities of facility, utilities, processes, equipment, instrumentation and to ensure FDA requirements are met.
Essential Duties And Responsibilities
- Working across functions, to ensuring the site’s quality system processes related to GMP compliance of the facility, equipment, computer systems and processes.
- Work with validation and engineering teams to provide Quality oversight for validation and qualification activities and ensure work is performed in a compliant and controlled manner.
- Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on all quality related matters is provided to the site.
- Support and ensure compliance of product and process transfers, including validation, from and/or to other manufacturing sites.
- Support implementation and quality oversight related to the overall compliance of the facility, equipment, and manufacturing processes.
- Support quality processes and systems across the product lifecycle including, but not limited to, change control, CAPA, deviations and investigations, label control, laboratory control, product quality complaints, Annual Product Quality Review (APQR), and management notification.
- Provide quality review and support for calibration and maintenance programs and ensure they are run in accordance with GMP regulation.
- Participate in or lead quality risk analysis.
- Proactively identify and work collaboratively to resolve problems taking risk-based and compliant approaches to solutions.
- Promote a quality mindset and quality excellence approach to all activities.
- Promote a safety mindset and focus on safety for all operations activities.
- Travel (up to 5%) may be required.
Basic Qualifications And Capabilities
- Bachelor’s degree in a scientific discipline with a minimum of 4 years Quality/cGMP experience in the pharmaceutical industry.
- Experience in facility and equipment qualification, process validation, LIMS systems, and calibration and maintenance programs.
- Knowledge in 21CFR Part 11, Electronic Records and Signatures and data integrity is required.
- Strong project management, organization, and execution skills to manage multiple projects and priorities.
- Participation and leading activities to support regulatory agency inspections required.
- Self-motivated, flexible, and able to work in a small, fast-paced, dynamic, environment.
- Ability to work autonomously and within established guidelines, procedures, and practices.
- Serve as a Quality subject matter expert to support driving investigations to root cause.
- Leverage experience and share industry best practices to support continuous improvement of site procedures.
- Committed to delivering high quality results, working with others to overcome challenges, and focusing on what matters.
- Continuously looking for opportunities to learn, build skills and share knowledge with others. Excellent interpersonal and written communication skills and experience using various software/electronic applications required
Preferred Qualifications
- Experience across the product development and commercialization lifecycle including change management and associated implementation strategies.
- Technical expertise in sterile pharmaceutical isolator technology, combination product and medical devices.