Job Type: Contract
Job ID: JO-2003-22550
Consultant: Sarah McEllistrem
Are you a QC Specialist with 5+ years experience with computerised quality systems and have experience in regulated biotechnology?
Do you have superuser knowledge of laboratory systems such as LIMS and Empower software?
If you have the relevant experience, please forward your CV to firstname.lastname@example.org for review or call 353 1 7978720 to discuss in confidence.
Quality Specialist - LIMS/Empower - Dublin
Our client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoighaire, South Dublin.
The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
This is an excellent opportunity to get experience on Ireland's leading aseptic manufacturing plant. Contractors have a history of either extending their contract or being offered permanent positions on this site.
Acting as Business Process Owner for LIMS and Empower ensuring the establishment, implementation and maintenance of these systems to the applicable Quality standards established by the FDA, MHRA, and other regulatory bodies.
Responsible for leading, coordinating, facilitating, and undertaking activities pertaining to LIMS and Empower, without direct supervision
Focus on Compliance, Continuous Improvement, a Lean Culture and Right First Time (RFT)
Assist Management and staff with LIMS and Empower related issues
Provide direction and advice to support the LIMS and Empower computer-related systems
Interface routinely with staff across the company regarding global Quality procedures as well as LIMS and Empower related questions
Interface with internal customers in Product Development, Quality, Manufacturing, Analytical Sciences, etc.
Ensure compliance with company requirements and GMP quality standards
Provide support to Chemistry and Manufacturing Controls (CMC) regulatory activities, to facilitate regulatory approval of the Company’s manufacturing facility and products
Support compliance and Quality Systems: audits, vendor qualification, change control, deviation and investigation management, corrective and preventative action systems, in-process, release and stability testing
Complete training on an ongoing basis as well as maintain complete training records
Potential to manage Quality contractors and consultants to enable initiation and maintenance of LIMS and Empower
Draft, review, provide oversight where appropriate to content, and approver controlled documents which may include but is not limited to product specifications, standard operating procedures, validation documents, quality policies, etc.
Provide input in the establishment and implementation of new LIMS and Chromatography systems along with validation philosophies and strategies for future global growth
Bachelor’s degree in a related field is required.
5+ years of experience in Quality Systems, regulated biotechnology, QC experience and GMP laboratory experience in the pharmaceutical or medical device industry.
Superuser LIMS and/or Empower experience (thermo LIMs experience preferred)
Appropriate GXP training.
Knowledge of FDA and MHRA guidelines regarding GMPs
Keen interest is troubleshooting lab system issues and Continuous Improvement
Hourly Rate €45 - €55 per hour
Minimum 12 month contract
Karen McHugh is the consultant managing this position.
If you are a Chemistry QC Analyst interested in roles based in Dublin , you can contact Karen by e-mail email@example.com or phone +353-1-7978720 for a confidential chat.
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With over 50 years of technical recruitment experience, JobContax is the leading recruiter of Chemistry QC Analysts in Dublin and Ireland.
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