QC Microbiology Specialist
Exciting opportunity for a QC Microbiology Specialist with our client, a leading pharmaceutical company based in Swords.
The QC Microbiology Specialist will be responsible for ensuring efficient and effective compliance, qualification, and operation of a Drug Substance facility. The successful candidate will work with a high performing cross‑functional team of talent sourced from across the company and the biotechnology industry.
Responsibilities include:
* 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.
* Accountable 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 change control process and mechanisms required to maintain a state of continued compliance for the methods.
* Author/review technical documents, standard operating procedures and actions for the performance of laboratory methods.
* Serve as an SME for regulatory and internal inspections and audits.
* Follow the current analytical practices with reference to pharmacopoeias, specifications, regulations, and industry standards.
* Writing and updating SOPs.
* Manage deviations, CAPAs and change controls.
* Ensure training is current for all job functions performed.
Requirements:
* 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.).
Skills:
* Excellent organisational skills.
* Good verbal and written communication skills.
* Excellent troubleshooting and problem‑solving skills.
* Attention to detail.
* Ability to think logically and be proactive.
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