A QC Manager is required for a Biopharmaceutical company based in Dublin.
The role is a critical position to the company as it oversees the Chemistry and Micro teams. The role has approx. 15 reports. The lab however is primarily chemistry focused.
- Co-ordinate receipt, testing, release or rejection of the following, Raw Materials, In-process Intermediates, APIs, Waste samples, Environmental samples
- Adherence to Visual management (e.g. Schedule boards) to improve practices and efficiency within the Laboratory areas.
- Operational excellence activities through support to HK projects
- Review and approval of specifications and procedures related to quality of raw materials, intermediates and APIs
- Review and approval of Protocols and validation documents to support process changes and qualifications.
- Management of Change control within the Laboratories to ensure adequate assessment of risks and correct implementation.
- Management and maintenance of Stability program for commercial APIs, including generation of stability APQR
- Ensure that Out-of-Specification investigations and laboratory deviations are completed and appropriate corrective actions identified and implemented
- Statistical Process control to ensure that the processes can be monitored
- Manage the Sampling, testing and release of the Purified Water system
- Manage the Environmental Monitoring of the Cleanrooms
- Ensure that all critical equipment is under a routine calibration and maintenance program. Organise annual maintenance contracts for critical systems in the QC Laboratory
- Manage Raw Material vendor evaluation
- Support validation and transfer of analytical methods to the QC laboratory.
- Recruitment of personnel with appropriate qualifications and experience through candidate selection, liaising with HR and interview process.
- To keep up-to-date with cGMP regulations
- Ensure that personnel are adequately trained in QC laboratory operations and ongoing development of personnel
- Conduct performance appraisals with personnel providing regular feedback on performance and expectations.
- Perform Resource planning to ensure that the group can support the business needs for strategic goals.
- To manage annual expense budget appropriately
- To identify capital requirements on an annual basis and complete justification for spend
- Act as a Direct Interface with Auditors, representing the company during Regulatory inspections and answering questions as required.
- Attend LMT meetings and liaise with other departments to ensure that the needs of the business are met
- To facilitate implementation of change due to changing regulations
- Liaise with external suppliers for equipment contracts and purchasing activities.
- Ensure knowledge of all analytical methods, procedures and techniques in the QC Laboratories
- Keep up-to-date with new alternative analytical technique
- Motivate QC personnel and assist in the development of their skills
- Attend Global meetings
Education and Experience
- BSc. In Science (Analytical Focus)
- 4 years' experience including at least 2 yrs in a QC Laboratory in a senior role. Experience in release of materials including APIs is essential. Experience in managing technical functions within cross-functional teams within Quality.
- Proven ability to lead a team.
Morgan McKinley is acting as an Employment Business in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.