QC Training and Compliance Specialist
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| Job Type | Contractor |
| Area | Westmeath |
| Sector | Laboratory/Scientific |
| Start Date | |
| Advertiser | Mary King |
| Job Ref | 2408 |
| Job Views | 311 |
- 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.
