Job Description
The Quality Control Manager will set up, organise and run the day to day operations of pharmaceutical QC testing laboratory while leading the QC team in carrying out analysis on Incoming Materials, Components and Products (including stability and other samples) and data to support manufacturing and QC functions. You will ensure that QC functions operate in a fully GMP compliant manner and in compliance with the filed regulatory dossiers for the products supported. You will be required to manage the day to day of a team of Analysts and Senior Analysts and drive compliance with work to agreed timelines.
The QC Manager will be responsible for the safety of team members, ensuring that all staff are suitably qualified and trained to undertake the tasks assigned to them in a safe and compliant manner.
It will be the duty of the QC Manager to train, coach and mentor team members primarily by acting as a positive role model in all instances while providing technical support/advice and guidance for QC testing to ensure that the test methods are robust and drive improvement of test methods.
You will be required to write, review, approve and implement SOP's, methods, protocols, method/equipment validation, method development/transfer and reports as required and be able to follow and have a detailed understanding of specifications for sample analysis you will ensure the Stability program operates efficiently and supports product shelf life to meet regulatory requirements as well as managing documentation, laboratory systems and processes updating as required.
The QC Manager will be required to be involved in both internal and external audits and provide responses to auditor's questions. You will need experience in identifying out of specification, atypical results and trend while leading/authorising laboratory investigations, Deviations and Change control measures.
The Quality Control Manager will need to be able to highlight potential issues rapidly to the relevant people in a clear, concise and timely manner offering solutions when appropriate while seeking best practice approaches and shares within the team and to a wider audience.
You will act as a Subject matter expert for Laboratory systems and Stability testing.
Required Skills:
Degree in Chemistry, Pharmaceutical Science, analytical or related.
Proven experience of 3-5 years as QC Manager or 5-7 years as Deputy Manager running QC or testing team from within the pharma.
Strong hands-on experience of undertaking testing, analysis and development using instrumentational analysis such as HPLC, Dissolution, FTIR and GC.in a cGMP environment.
Extensive knowledge of GMP, ICH guidelines, BP/EP/USP methods with a strong understanding of QA processes and methodologies.
Experience of LIMS or equivalent system is desirable
Strong Microsoft Office Suite experience
For further information on this QC Manager position please contact Laurentina Kennedy at The RFT Group on 01 2302400 / Laurentina@rftgroup.ie. Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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