Quality Coordinator
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What you'll do
- Conduct root cause analysis and write formal investigation
- Collaborate with other areas (both internally and externally) as required to deliver comprehensive investigations
- Raise appropriate Corrective and Preventive Actions (CAPAs) to correspond with investigation outcomes and prevent recurrence
- Ensure timely completion of all TrackWise investigations / actions
- Complete other tasks using the electronic Quality Management System (e.g. change controls etc)
- When required raise deviations (QRs) in a timely manner
- Update processes within the electronic Documentation System (eDMS)
- Conduct risk assessments to identify potential issues and implement any required actions to reduce risk
- Develop and deliver training, provide coaching and support
- Assist in the introduction and implementation of new processes as required
- Support regulatory inspections, client and internal audits to ensure compliance
- Implement Practical Process Improvement (PPI) methods to update processes
What they're looking for
- Degree level preferred, experience in pharmaceutical, medical device or regulated industry preferred
- Additional certifications in Quality Systems or GMP preferred
- Experience with quality systems and documentation including batch records, SOPs, deviations, CAPA
- Proficiency in quality management and software systems (TrackWise, SAP, etc.)
- Strong analytical and problem-solving skills for quality investigations and root cause analysis
- Excellent written and verbal communication skills
- Ability to work independently and collaborate effectively with cross-functional teams
- Proficient computer skills including Microsoft Office applications
- Strong attention to detail and commitment to accuracy
- Ability to prioritize and adapt in a changing environment
- Experience with continuous improvement methodologies preferred
Nice to have
- Degree level preferred, experience in pharmaceutical, medical device or regulated industry preferred
- Additional certifications in Quality Systems or GMP preferred
- Experience with continuous improvement methodologies preferred
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
DESCRIPTION:
As a Quality Coordinator, you will play a critical role in our operational quality team, ensuring any issues are investigated and solutions implemented to prevent recurrences. Your work will impact on production and delivery of our products, to meet client expectations.
• Conduct root cause analysis and write formal investigation
• Collaborate with other areas (both internally and externally) as required to deliver comprehensive investigations
• Raise appropriate Corrective and Preventive Actions (CAPAs) to correspond with investigation outcomes and prevent recurrence
• Ensure timely completion of all TrackWise investigations / actions
• Complete other tasks using the electronic Quality Management System (e.g. change controls etc)
• When required raise deviations (QRs) in a timely manner
• Update processes within the electronic Documentation System (eDMS)
• Conduct risk assessments to identify potential issues and implement any required actions to reduce risk
• Develop and deliver training, provide coaching and support
• Assist in the introduction and implementation of new processes as required
• Support regulatory inspections, client and internal audits to ensure compliance
• Implement Practical Process Improvement (PPI) methods to update processes
• Provide general support to all operational areas, ensuring a Quality culture
• Undertake any other adhoc duties as required
REQUIREMENTS:
• Degree level preferred, experience in pharmaceutical, medical device or regulated industry preferred
• Additional certifications in Quality Systems or GMP preferred
• Experience with quality systems and documentation including batch records, SOPs, deviations, CAPA
• Proficiency in quality management and software systems (TrackWise, SAP, etc.)
• Strong analytical and problem-solving skills for quality investigations and root cause analysis
• Excellent written and verbal communication skills
• Ability to work independently and collaborate effectively with cross-functional teams
• Proficient computer skills including Microsoft Office applications
• Strong attention to detail and commitment to accuracy
• Ability to prioritize and adapt in a changing environment
• Experience with continuous improvement methodologies preferred
Company
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