Apply Now

Job ID: JOB-13604

QC Microbiology Manager

Our Client is looking to attract a qualified Quality Control Microbiology Manager to join their team in Limerick on a permanent basis.

As a Manager within the QC Microbiology department you will manage the QC Microbiology team and provide critical microbiology support to manufacturing and facilities.

This is an excellent opportunity for someone with a microbiology background and leadership experience to join a global leader in the field of Bio-Tech!

In this role. your typical day might include,, but will be not limited to, the following:

• Manage a team of laboratory analysts within the QC microbiology department involved in the analysis of raw materials, intermediates (in process) and bulk drug substance in a cGMP regulatory environment.
• Implement and manage the environmental monitoring programme, including surface, settling and viable and non-viable particulate air monitoring of aseptic operations and controlled areas.
• Responsible for all QC microbiological aspects of cGMP compliance and sample analysis.
• Design and oversee microbiological validations as needed for drug substance, in-process controls and buffers.
• Manage the design, validation and execution of the clean utilities qualification and re-qualification program.
• 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.
• Ensure that all work carried out is in compliance with the required regulatory standards, conforms to company policies and standard operating procedures (SOPs).
• Review and approve method protocols, reports and SOPs.
• Assist in the preparation for internal/customer/regulatory inspections.
• Oversee or conduct laboratory investigations and generates reports in response to invalid assays, Deviations, OOS/OOT.
• Ensure that CAPAs and Change Controls are initiated and completed on time and in accordance with site procedures.
• Train, develop and mentor direct reports and effectively manage the performance of individuals.

 Key Requirements

• To be considered for this position you must hold a BS/BA in Microbiology or closely related field
• 7+ years’ relevant experience preferably in the pharmaceutical or biotech industry.
• People management experience

Key Selling points:

1. Highly competitive salary.

2. Excellent career progression with stats to prove this.

3.Re-location package if applicable

4. Generous bonus & comprehensive benefits package.

For further information on this role in please contact Mark Wilson on 0860449473 or email talent@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

Mark Wilson

JOB-13604

Apply Now