QC Microbiology Support Manager


Premium Job From Real Staffing

Recruiter

Real Staffing

Listed on

10th January 2018

Location

Limerick

Salary/Rate

£66312 - £67152

Type

Permanent

This job has now expired please search on the home page to find live IT Jobs.

I am recruiting for an exciting QC Microbiology Support Manager position for a Biotech start up.

This is a brand new position with a Global Biopharmaceutical Company based in Limerick. There has been a new structure in the Micro department and this new team will liaises with the Microbiology department and Quality Assurance to ensure all investigations are aligned and audit ready.

The successful candidate will be responsible for the management of a team of analysts within the QC Microbiology department for a cGMP biopharmaceutical manufacturing facility.

Responsibilities

* Manage a team of analysts within the QC Microbiology department involved in the review of raw materials, intermediates (in process) and bulk drug substance testing in a cGMP regulatory environment.

* Responsible for all QC microbiological aspects of cGMP compliance and review of sample analysis.

* Support manufacturing personnel in the identification of microbiological root cause analysis and provide technical advice on QC related topics as needed.

* Participate in the investigation and review of alert and action limit investigations as needed and implements corrective action as appropriate.

* Assist in the preparation for internal/customer/regulatory inspections.

* Oversees or conducts laboratory investigations and generates reports in response to invalid assays, Deviations, OOS/OOT.

* Ensures that CAPAs and Change Controls are initiated and completed on time

Requirements

* Requires BS/BA in Microbiology or related life sciences discipline and 7+ years of relevant experience within the pharmaceutical or biotechnology industry along with previous supervisory and/or leadership experience.

* * Experience with electronic systems such as LIMS, Qumas, eDoc, Trackwise etc, is an advantage.

* In depth knowledge of current regulatory requirements in support of cGMP manufacturing operations.

The company have a strong culture of R&D and Innovation and offer successful candidates huge progression and development opportunities. Please get in contact today

Sthree UK is acting as an Employment Agency in relation to this vacancy.

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