QC Microbiology Specialist

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