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Job ID: JOB-13390

Quality Control Manager

Our Galway based Pharmaceutical Client are seeking a Quality Control Manager to join their team on a permanent basis. They will provide technical expertise to assist in the analytical testing on finished product & raw materials using the correct procedures in order to comply with GMP, Health and Safety, SOP’s and environmental and regulatory requirements while ensuring they meet their customer’s needs.

Reporting to: Head of Quality.

KEY RESPONSIBILITIES:

• Ensure that all testing is conducted in accordance with current EU and US regulatory requirements. Data integrity is of paramount importance and must comply with current guidelines.
• Ensure completion of testing to allow for timely release of raw materials for use in manufacture and finished product for release to the market.
• Maintenance of the QC stability testing program.
• Ensure timely review and approval of laboratory results, protocols and reports.
• Provide technical guidance in the event of equipment failure, calibration failure, out of specification results and any other issues as appropriate. Ensure all laboratory equipment is maintained and calibrated.
• Perform detailed root cause investigations into out of specification results or any analytical errors that occur in the laboratory.
• Ensure timely completion of method transfer activities in accordance with relevant procedures.
• Ensure method development and validation is conducted in accordance with the relevant regulatory procedures and in adherence with the agreed timeframe.
• Ensure adherence to all relevant Standard Operating Procedures (SOPs), Calibration and Operation Instructions (COIs) and existing test methods with reference to pharmacopoeia’s, specifications, regulations and industry standards.
• Scheduling of analysis, prioritising work across and in conjunction with  Jordan Laboratory.
• Ensure statistical trend analysis is completed in accordance with current GMP/GLP requirements.
• Review all laboratory notebooks, records, chromatograms etc. to an acceptable GLP standard and up to date at all times.
• Assist the Head of Quality in hosting Regulatory inspections and Customer audits.
• Ensure that corrective actions identified as a result of observations raised during regulatory & customer audits are implemented in a timely manner.
• Ensure that all GMP/GLP related documentation is regularly reviewed and updated in accordance with Company policy.
• Review and approve company standard operating procedures.
• Provide monthly measurements on Key Performance Indicators (KPI’s) to reflect the performance of the Laboratory function.
• Conduct performance reviews with Laboratory personnel in accordance with the Company performance management system.
• Identify training and on-going development opportunities for laboratory personnel and training records maintained.
• Ensure that continuous improvement initiatives are identified and implemented in the laboratory as appropriate.
• Assist in the selection and recruitment of Laboratory personnel in conjunction with Human Resources.
• Monitor the laboratory capacity to ensure that the resources meet the requirements of the business and take appropriate corrective measures as required.
• Ensure the laboratory operates within the requirements of the budget on a monthly basis.
• Any other duties assigned by the Head of Quality.

QUALIFICATIONS:

• 3^rd level qualification – Bachelor’s degree in a science-based discipline.
• Minimum of 5 years in a pharmaceutical’s environment.
• Strong computer skills in MS Office
• Experience working within a pharmaceutical cGLP Environment; with knowledge of EU GMP and US FDA Guidelines

For further information on this role in please contact Mark Wilson on 0860449473 or emailtalent@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-13390

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