Stability/ Validation Analyst, Pharmaceutical
Posted 20/05/2024 by Russell Taylor Group Ltd
Stability/ Validation Analyst, Pharmaceutical
Type: Permanent
Location: Derby
Salary: Upto £24000 - £31000 depending on experience
Hours: Days (Mon - Friday)
Our client, a leading Pharmaceutical manufacturer (CMO) is looking to recruit for an experienced HPLC/GC Analyst; the successful candidate will gain furthered career progression working in the stability/ validation testing department.
The Role:
• Analytical testing according to cGMP/GLP, SOPs and Work Instructions, QC analytical project testing and primarily stability testing.
• To assist the stability programme.
• To produce documentation to support the stability programme, including generating protocols, reports, trial discontinuation and stability data tables.
• Conduct stability trial initiations.
• To assist and maintain stability programme product trending.
• To assist with the maintenance and checks of stability cabinets.
• Assist with up keep of laboratory documentation.
• Act as a signatory for laboratory documentation, Work Instructions and SOP's as author or reviewer.
• Advice senior staff of deficiencies in instrumentation and equipment ensuring that the Supervisors are informed of any potential delays or problems, be pro-active.
• Ability to troubleshoot analytical and equipment problems, be pro-active.
• Be able to conduct and investigate OOS results with the assistance of line management.
• Carry out calibration tasks as delegated by the supervisor.
• Ensure Validation & Stability Manager/QC Lab Manager are informed of any potential delays or problems.
• Ensure Stability Studies, are completed and reviewed within time scales that meet the business needs.
• Escalate non-resolvable technical/quality issues to management
• Assist with training of laboratory staff.
• Gain experience in using HPLC, GC or AA.
• Ensure the laboratory is kept to a standard that meets cGMP and would pass all audits.
• Support other areas of the laboratory as required including calibration and cleaning responsibilities.
• Provide support in the execution of validation tasks and paperwork.
• Provide support in the execution of project tasks and paperwork.
• Other tasks assigned by Validation & Stability Manager
The Person:
• Will hold a Degree in a relevant - Scientific discipline (will be Analytical based - Pharmaceutical, Chemistry etc)
• Solid experience in HPLC-UV, GC testing with experience in troubleshooting in an GLP/ GMP setting or similar.
• The ideal candidate will have experience in method development and/or method validation
Important Information: We endeavour to process your personal data in a fair and transparent manner. In applying for this role, Russell Taylor will be acting within your interest and will contact you in relation to the role, either by email, phone or text message. For more information see our Privacy Policy on our website. It is important you are aware of your individual rights and the provisions the company has put in place to protect your data. If you would like further information on the policy or GDPR please get in touch with us here.
Type: Permanent
Location: Derby
Salary: Upto £24000 - £31000 depending on experience
Hours: Days (Mon - Friday)
Our client, a leading Pharmaceutical manufacturer (CMO) is looking to recruit for an experienced HPLC/GC Analyst; the successful candidate will gain furthered career progression working in the stability/ validation testing department.
The Role:
• Analytical testing according to cGMP/GLP, SOPs and Work Instructions, QC analytical project testing and primarily stability testing.
• To assist the stability programme.
• To produce documentation to support the stability programme, including generating protocols, reports, trial discontinuation and stability data tables.
• Conduct stability trial initiations.
• To assist and maintain stability programme product trending.
• To assist with the maintenance and checks of stability cabinets.
• Assist with up keep of laboratory documentation.
• Act as a signatory for laboratory documentation, Work Instructions and SOP's as author or reviewer.
• Advice senior staff of deficiencies in instrumentation and equipment ensuring that the Supervisors are informed of any potential delays or problems, be pro-active.
• Ability to troubleshoot analytical and equipment problems, be pro-active.
• Be able to conduct and investigate OOS results with the assistance of line management.
• Carry out calibration tasks as delegated by the supervisor.
• Ensure Validation & Stability Manager/QC Lab Manager are informed of any potential delays or problems.
• Ensure Stability Studies, are completed and reviewed within time scales that meet the business needs.
• Escalate non-resolvable technical/quality issues to management
• Assist with training of laboratory staff.
• Gain experience in using HPLC, GC or AA.
• Ensure the laboratory is kept to a standard that meets cGMP and would pass all audits.
• Support other areas of the laboratory as required including calibration and cleaning responsibilities.
• Provide support in the execution of validation tasks and paperwork.
• Provide support in the execution of project tasks and paperwork.
• Other tasks assigned by Validation & Stability Manager
The Person:
• Will hold a Degree in a relevant - Scientific discipline (will be Analytical based - Pharmaceutical, Chemistry etc)
• Solid experience in HPLC-UV, GC testing with experience in troubleshooting in an GLP/ GMP setting or similar.
• The ideal candidate will have experience in method development and/or method validation
Important Information: We endeavour to process your personal data in a fair and transparent manner. In applying for this role, Russell Taylor will be acting within your interest and will contact you in relation to the role, either by email, phone or text message. For more information see our Privacy Policy on our website. It is important you are aware of your individual rights and the provisions the company has put in place to protect your data. If you would like further information on the policy or GDPR please get in touch with us here.
- Type:
- Permanent
- Start Date:
- 20/05/2024
- Contract Length:
- N/A
- Contact Name:
- Login or register to view
- Job Reference:
- J91978928
- Job ID:
- 221687417
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