QC Microbiology Specialist

1 week ago

Dublin, Ireland Claran Consultants Ltd Full time

Role Description A great opportunity has arisen for a QC Microbiology Specialist. The QC Microbiology Specialist role is a critically important role to ensure efficient and effective compliance, qualification, and operation of the Drug Substance facility. The facility will utilize the latest innovations in technology and automation and latest in analytical techniques. The candidate will work with a high performing cross functional team of talent sourced from across the company and the biotechnology industry. Role Functions (Functions include, but are not limited to, the following) Perform and support QC analytical activities including in-process, release and stability related testing. Provide day to day direction and scheduling to the QC analyst team. Responsible for the qualification, maintenance, and/or integration of the QC methods, in compliance with up-to-date data integrity, regulatory, and industry standards. Responsible for driving a culture of Continuous Improvement. Ensure that cGMP standards are maintained at all times. Accountable for change control process and mechanisms required to maintain a state of continued compliance for the methods. Manage deviations, CAPAs and change controls. Author/review technical documents, standard operating procedures and actions for the performance of laboratory methods. Participate in risk assessments and implement and follow-up on corrective / preventative measures. Serve as an SME for regulatory and internal inspections and audits. Work cross-functionally to build and operate testing capability within the lab. Escalates potential cGMP or compliance issues effectively in a timely manner for proper resolution to ensure product quality. The motivation to be an inspiring member of a high performing team. The desire to continuously learn, improve and develop. Follow up-to-date analytical practices with reference to pharmacopoeias, specifications, regulations, and industry standards. Writing and updating SOPs. Ensure training is current for all job functions performed Maintain data integrity and ensure compliance with company SOPs, specifications, and cGMP regulations Experience, Knowledge & Skills Experience: 5 years industry experience with significant knowledge and experience working in a Microbiology Laboratory in a pharmaceutical company Experienced in testing as per the pharmacopeias Working knowledge of QC Digital Systems (eLogs, Electronic Lab Notebook, LIMS etc.) Skills: Ability to respond to changing priorities Strong organisational skills Good verbal and written communication skills Excellent troubleshooting and problem-solving skills Good attention to detail Ability to think logically and be proactive Ability to work as part of a team and on own initiative in a constructive manner Flexible and self-motivated Qualifications & Education Qualification: Bachelors Degree qualification (Science, Microbiology preferred) Skills: Microbiology Drug Substance CAPA SOP

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