Job Description
An exciting opportunity has arisen for a Quality Assurance Contamination Control Specialist in our state-of-the-art Single Use (SU) Drug Substance manufacturing facility in Dunboyne Biologics, Meath.
As part of this role, you will directly support the Contamination Control Team reporting to the site Plant Microbiologist. You will provide technical oversight to the Microbiology testing laboratory, Manufacturing and Technical Operations teams. You will have oversight of, and provide technical expertise to the environmental monitoring, product testing and contamination control programs for the site, consistent with company's requirements to ensure compliance, safety, and reliable supply to our customers.
What you will do:Bring energy, knowledge, innovation, and leadership to carry out the following:
Oversight to develop and implement quality control procedures to prevent contamination during the production and QC testing processes.Conduct regular inspections of production and plant utility areas, equipment, and materials to identify and advise mitigation for any potential sources of contamination.Collaborate with other departments to investigate and resolve contamination events or deviations from quality standards, ensuring that any Out of Specification (OOS) or Out of Trend (OOT) results are managed and responded to appropriately and oversee the program governing this response.Attend and contribute to Quality Risk Management (QRM) Assessments (QRA) for contamination control.Maintain a current knowledge of industry regulations and best practices related to contamination control and quality assurance by liaising with global teams, attending Community of Practice meetings, conferences etc.Prepare for, and support, internal and external audits (e.g. HPRA, FDA, corporate, customer). Actively lead and support projects, quality initiatives and continuous improvement programs within the Quality department and in other functional areas, for contamination control, regulatory compliance and continuous improvement.Coach and mentor the Laboratory and Manufacturing Operations Teams to work with a contamination prevention and control mindset.What education, experience and skills you will need:In order to excel in this role, you will need:
Bachelor's Degree or higher, in a relevant field such as biology, microbiology, or a related scientific discipline.Over 4 years' experience in the pharmaceutical industry or a similar operating environment. Experience in quality control, quality assurance, or contamination control in a relevant industry.Experience in participating and contributing to contamination risk assessment.An understanding and knowledge of GMP, ICH, USP and global compendia regulations and guidance.Strong knowledge in microbiology related lab test methods e.g. Environmental Monitoring, Microbial Identifications, plate reading, bioburden testing, endotoxin testing etc.Strong attention to detail, and a thorough understanding of contamination risks and mitigation strategies are essential for this role.Strong project management skills to support project delivery and operational readiness with a proven ability to lead cross functional teams and deliver on tight timelines.Excellent influencing/collaboration skills and teamwork mindset.Perform tasks with a high degree of precision and accuracy.This role is based on site.
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