Job ID: JOB-12106
QC LAB MANAGER
Our Client, a leading Pharmaceutical company based in Galway are looking to attract a QC Lab Manager on a permanent basis. We are looking for individuals who will support and drive their vision to be the most valued global provider of high quality, competitively priced pharmaceutical products and to provide excellent services and support to their customers.
- Ensure completion of testing to allow for timely release of raw materials, in process and finished product in line with production requirements, release schedules and customer requirements.
- Ensure timely review and approval of laboratory results, protocols, reports, SOP’s and other documentation as appropriate.
- Ensure that the analytical laboratory operates in compliance with cGMP requirements.
- Provide technical guidance in the event of equipment failure, calibration failure, out of specification results and any other issues as appropriate.
- Provide assistance to the Qualified Person’s in the role of performing product disposition.
- 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 timely completion of Cleaning Validation analysis and protocol review
- Assist the Head of Quality in represent the laboratory during 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 related documentation is regularly reviewed and updated in accordance with Company policy.
- Review and approve company standard operating procedures.
- Ensure that product quality review reports are prepared by the laboratory personnel in a timely manner.
- Conduct external audits of vendors, contract laboratories and contract manufacturers as appropriate.
- Assist in the appropriate selection, approval and on-going monitoring of contract laboratories is performed.
- Assist in the review of Technical Agreements with contract laboratories behalf of Realoch.
- Provide details on Key Performance Indicators (KPI’s) to reflect the performance of the Laboratory function.
- Carry out performance reviews with Laboratory personnel in accordance with the Company performance management system.
- Identify training and on-going development opportunities for laboratory personnel.
- Ensure that training records are 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.
- Participate in initiatives with suppliers of laboratory consumables, contract laboratories & service providers on a regular basis to negotiate pricing and to incur cost savings.
- Lead by example ensuring that your work area is kept tidy and that GLP/GMP standards are adhered to at all times
- Knowledge in analytical techniques (Such as HPLC, GC, IR, and various wet chemistry techniques)
- 10 years of experience in the laboratory as per GMP requirements
- Good verbal and written communication skills and the ability to work independently in analytical; environment
- Good computer skills with Word, Excel and any other statistical programs
- Knowledge of Process and Cleaning Validation
- Abel to conduct internal and external regulatory audits
For further information on this role in please contact Mark Wilson on 0860449473 or email email@example.com
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.
Apply Now Job ID: JOB-12164 Quality Control Supervisor Duration: 12 Months We are now recruiting a Quality Control Supervisor to…
Apply Now Job ID: JOB-12161 Network Architect My client a healthcare delivery enterprise are looking for a Network Architect to…
Apply Now Job ID: JOB-12163 Process Technician – Injection Moulding Key Responsibilities: Work with Manufacturing Engineers in developing, trouble shooting,…