QC Training and Compliance Specialist
| Job Type | Contractor |
| Area | Westmeath |
| Sector | Laboratory/Scientific |
| Start Date | |
| Advertiser | Mary King |
| Job Ref | 2408 |
| Job Views | 208 |
- Description
- We are seeking applications for an experienced QC Training and Compliance Specialist to join our client site in Dublin on an initial 9-month contract.
Why you should apply:- This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
- There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
What you will be doing:- Oversight of the training program for the QC department including the delivery of training on technical topics to the QC team.
- Design and maintenance of a robust onboarding and training program for new starts to the QC team.
- Develop and deliver technical training as required and support development of SME’s within the Microbiology team
- Identify, lead and implement continuous improvement initiatives which ensure maintenance of cGLP, inspection readiness, data integrity and eliminate/reduce risk
- Lead the introduction of new methods/techniques/technologies into the QC Microbiology laboratory and ensure compliance of existing methods/processes to compendial and regulatory requirements
- Manage the continuous improvement program for QC including planning and facilitating workshops and supporting the translation of the output to procedural/process updates.
- Documentation flow and paperwork practices – Improving Right First Time and reducing GDP errors within QC and implementing processes to track and trend performance against targets
- Support investigation of major laboratory investigations, identifying and implementing robust CAPA’s to prevent recurrence
- Develop simplified and effective scheduling for routine/non routine activities to maximise available resources
- Generation of QC metrics and presentation of metrics to QC management on a monthly basis
- Actively participate in and support inspection readiness for the QC Department acting as SME as required
- Present and report on project progress and continuous improvement to QC management on a monthly basis
- Maintain regular and proactive communication with all stakeholders.
What you need to apply:- At least 5 years’ working in a GMP Quality Control Laboratory
- BSc./MSc. Degree in science/pharmaceutical related subject (preferably Microbiology)
- Knowledge and understanding of GMP/GDP standards
- Strong problem solving and leadership experience
- Experience in workshop facilitation
- Experienced in leading and executing continuous improvement initiatives
- Experience of SOP authoring and document management processes
- Highly Computer literate, with MS Office (Word, Excel)
- Experience of provision training to others
- Good working knowledge of QC Microbiology and lab practices and troubleshooting
- Knowledge and experience with Chemistry instrumentation and methods is beneficial but not essential
- An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.
- Excellent communication & presentation skills are essential.
- Excellent time management organizational skills along with a proven ability to multi-task.
