Job Description
Our Client is a dynamic and growing global specialty-driven biopharmaceutical company focused on innovation and specialty care.
The Quality Control Manager will manage the Quality Control Laboratory and ensure that all laboratory operations are carried out in compliance with all EHS, cGMP and regulatory commitments.
To ensure prompt release testing and disposition of materials to meet the requirements of manufacturing and supply of Active Pharmaceutical Ingredient (API).
Improve cycle times and service level agreements (SLA) through continuous improvements and alignment of QC with the changing business needs.
To develop QC personnel and provide technical development which will foster ambition, creating an environment that strives for excellence and secures the talent pool. To promote QC within the Dublin site as a strong reliable team that supports the business needs and demonstrates a proven track record of delivery
Main responsibilities
- 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 the 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.
- 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 the annual expense budget appropriately
- To identify capital requirements on an annual basis and complete justification for spend
- Act as a Direct Interface with Auditors, during Regulatory inspections and answering questions as required.
- To keep up to date with cGMP regulations
- To facilitate the implementation of change due to changing regulations
- Attend LMT meetings and liaise with other departments to ensure that the needs of the business are met.
- Attend Global meetings (Teleconference, Webex, Face to Face) as required. For example, Signes Quality, LIMS User Meetings, MICE, etc.
- 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 techniques
- Motivate QC personnel and assist in the development of their skills
Experience & Qualifications:
At least 5 years of relevant Pharmaceutical Laboratory experience. Significant experience in managing a technical function within cross-functional teams. Proven success in leading a Laboratory, including experience with inspections (FDA and HPRA). Proven ability to lead a team and earn respect/influence senior colleagues in a cross-functional, global environment
The role is based in Nr Dublin it is a maternity leave contract role report into the Director of Quality within the Quality department
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