Matrix Recruitment
are currently recruiting for a QC Micro Specialist on behalf of our client based in Dublin.
Your New Role:
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 company Drug Substance facility.
Key Duties and Responsibilities:
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.
Escalate potential cGMP or compliance issues effectively in a timely manner for proper resolution to ensure product quality.
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.
What you need:
5 years industry experience with significant knowledge and experience working in a Microbiology Laboratory in a pharmaceutical company.
Bachelor's Degree Qualification (Science, Microbiology preferred).
Experienced in testing as per the pharmacopeia's.
Working knowledge of QC Digital Systems (eLogs, Electronic Lab Notebook, LIMS etc.).
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