Biopharma/ Cell Data Reviewer
- Employer
- Thornshaw Recruitment
- Location
- Ireland (IE)
- Salary
- Negotiable depending on experience
- Start date
- 15 Mar 2023
- Closing date
- 29 Mar 2023
View more
- Discipline
- Quality, GMP, QC Analyst
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
My client, a global Contract Research Organisation, is currently recruiting for a Biopharmaceutical Data Review Scientist.
This position once onboarded will be remote enabled
Key responsibilities:
• Ensures the quality of laboratory data and reports.
• Evaluates data to ensure compliance with analytical methods, client criteria, and Good Manufacturing Practices (GMP).
• Performs Release, Stability, non-routine and complex analytical data reviews ensuring scientific soundness and method validation.
• Reviews chromatographic/electrophoretic data and related documentation as specified by Standard Operating Procedures (SOPs).
• Reviews sample results tables and analytical reports for completeness and accurate representation of the data and report findings.
• Communicates with laboratory staff to proactively address the quality of laboratory documentation.
• Prepares statements noting deficiencies with the analytical data set or documentation.
• Reports deficiencies to the project leader for correction.
• Trains new data Reviewers and laboratory staff. Performs other duties as assigned, including SOP review and writing.
• Conducts consultations for quality records.
Education and experience
• BSc in Science or related field required
• 2+ years of QA/QC experience required (gaining thorough knowledge of chromatography, and ideally also knowledge of electrophoresis, ELISA, compendial tests)
• Thorough knowledge of SOPs and FDA, EMA Regulations to include GMP
• Strong verbal and written communication skills
• Strong technical knowledge including an understanding of laboratory procedures, methodology and standards
• Ability to independently review laboratory reports and analytical methods
• Strong attention to detail
For a full Job Spec and to apply for this role please call Zoe on +353 1 2784671 or e-mail zhamilton@thornshaw.com
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671
Company
Thornshaw Scientific Recruitment was first established in 1999 and since then has become a leader in Scientific recruitment. In 2005 we partnered with Cpl Resources, one of Europe’s most successful recruitment companies.
Our wealth of experience in specialised recruitment allows us to offer the right solution to each employer, whatever their recruitment requirements.
Over the years we have developed strong relationships with our clients in the market and we pride ourselves on our repeat business from clients.
Our Industries
We are a global provider and have been providing a reputable recruitment service to the Biotech, Pharmaceutical, Clinical Research, Medical Device, Engineering and Healthcare industries for over 20 years.
Our Specialities
Clinical Research, Regulatory Affairs, Quality Assurance, Medical Affairs, Pharmacovigilance, Biostatistics, QC, Validation.
Our Mission
For further details on our services contact Tina at +353 1 2784701 or email tdunne@thornshaw.com
- Website
- http://www.thornshaw.com/
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