Document Technician – Temporary – 6 month contract to start

Prestigious Loughborough based pharmaceutical client is seeking a candidate to support the Manufacturing department and Supply Chain.  This role will include updating product specifications, Manufacturing batch records, Product Quality Reports and other relevant documents.  It requires the co-ordination of updates to multiple documents, ensuring accuracy and consistency for audit, and using MS Word and a bespoke document system.

We are seeking candidates who:

• Have  experience in Document writing, which may be the writing of SOP's or similar. This would need to be in Pharmaceutical, Aerospace or Food industries.
• Must be fully computer literate using Word and Excel.  Experience using bespoke programs would also be beneficial.
• Will understand the stringent requirements of working in a regulated environment.

In addition, the following attributes will be highly beneficial:

• Knowledge and application of current safety regulations and requirements.
• Actively raise and support the resolution of APR's, NM and MI's.
• Complete Risk Assessments as required.
• Effective Root Cause analysis for unplanned deviations using appropriate methodologies and site systems.
• Have working knowledge of  site documentation and change control systems and be able to prepare detailed and effective Change Control documentation.
• Be able to author product specifications, batch records, validation documents and associated reports, as well as any other specific technical documents as required.

Candidate will ideally have an awareness of current regulatory standards e.g. Eurdralex/Orange Guide and ISO standards for medical and sterile devices, and an understanding of manufacturing processes,  and an awareness of lab testing and key quality attributes, and their impact on the products.

The successful candidate will be educated to degree level or have equivalent experience in a relevant science/engineering discipline.   It would be desirable to have worked with a GLP, GMP, or ISO accredited organisation.

This role is initially a 6 month temporary assignment, with the strong possibility of it being extended.

Label Technician – Temporary

A highly regarded Loughborough based client is seeking a Label Technician to prepare and create templates to move existing labels from one system to another allowing them to be printed in production.

Duties will include;

• Mark up artwork to send to another site for creation of labels for production.
• Work closely with other functions as required, providing information on prioritisation.
• Update bill of materials, text lines using SAP and access database, update templates.
• Work alongside Planning team to prioritise the moving of the labels into production.
• Assist with the preparation and maintenance of departmental procedure.
• Support site improvement projects.
• Support new product introduction as required.

Candidates should all be EHS and GMP compliant and ideally have knowledge of Loftware and Codesoft.

37.5 hours per week. The role is initially on a 6 month temporary contract, however this could be extended to 12 months.

Label Technician – Temporary

A highly regarded Loughborough based client is seeking a Label Technician to prepare and create templates to move existing labels from one system to another allowing them to be printed in production.

Duties will include;

• Mark up artwork to send to another site for creation of labels for production.
• Work closely with other functions as required, providing information on prioritisation.
• Update bill of materials, text lines using SAP and access database, update templates.
• Work alongside Planning team to prioritise the moving of the labels into production.
• Assist with the preparation and maintenance of departmental procedure.
• Support site improvement projects.
• Support new product introduction as required.

Candidates should all be EHS and GMP compliant and ideally have knowledge of Loftware and Codesoft.

37.5 hours per week. The role is initially on a 6 month temporary contract, however this could be extended to 12 months.

QC Lab Technician – 6 Month Contract, potential to extend – Loughborough

We are currently working with a global client who are looking for a Lab Technician - £10.88 per hour

You Will Be Responsible For

Testing raw material samples for batch releases,
Calibration of instruments
Record keeping and Documentation

Job Requirements
1 year+ work experience in similar role desirable
Good understanding of HLPC and/or GC working experience
UV and IR experience, and knowledge of Wet Chemistry techniques.
Ideally Worked in GMP/pharmaceutical environment.
Degree in Chemistry, Forensic Science, or Pharmaceutical Science desirable

Minimum Entry level - 2 x science based A’levels OR BTEC Nat Diploma OR NVQ Level 3 or equivalent in relevant subject

Toolmaker

One of our key Loughborough clients has a sister site in Clitheroe, Lancashire, and we are delighted to offer a number of exciting new opportunities for Toolmakers to be based in Clitheroe, for this global pharmaceutical company.

The tool maker role involves the manufacture and setting of press tooling, routine maintenance, job change overs, and trouble-shooting of daily production issues.

 Rotating shift pattern 0600-1400/1400-2200, some weekend work will be required.

Main Responsibilities

• Manufacture and setting of press tooling, tooling corrections and refurbishment
• Daily checks to ensure quality standards are achieved. Problem solving of daily production issues
• Manufacturing of jigs and fixtures to enhance the site manufacturing capability
• Reading and interpreting technical drawings
• Operation of a range of precision equipment including lathes, milling machines, surface and cylindrical grinders.

• Maintaining a safe working environment
• Producing clear, concise and legible documentation

The Candidate

• Time served Toolmaker. City & Guilds in Mechanical Engineering or equivalent, with good manual bench skills

• Experience in deep draw transfer presses preferred but not essential
• Excellent fault-finding skills

• Strong mechanical background
• Ability to develop and learn new tasks
• GCSE or equivalent in English and Maths

• Confident interpersonal and organisational skills
• Computer literacy is desirable
• A senior Tool Setter with experience covering most of this brief may be considered

Benefits

• £25,000 - £28,000 depending on experience
• 25% Shift premium plus good benefits package
• Excellent opportunities

Analytical R&D Lab Analyst

Brilliant opportunity for a Laboratory Analyst to join an Analytical Research & Development team, based in Loughborough.  The department primarily conducts testing on Metered Dose Inhalers, primarily using HPLC based methodology. The department provides support to all other functions within the Research & Development division of this international company.  The role will involve testing of drug products from early Feasibility studies through to supporting activities associated with registration stability and full development.

Key Job Responsibilities

• Generate, record and report analytical data in line with departmental procedures
• Complete work and documentation to standards of compliance designated by external Regulatory bodies and internal Company procedures
• Investigate atypical results using basic problem-solving techniques
• Ability to suggest improvements and generate idea

Key Skills & Experience 

• Experience of pharmaceutical product testing in a GMP environment
• Experience of testing inhalation products is preferred but not essential
• Working knowledge of analytical instrumentation, preferably HPLC/UPLC, GC, IR and UV
• Experience of HPLC analysis is strongly preferred
• Experience of the development and optimisation of HPLC/UPLC methodology is preferred but not essential
• Experience of the theory and practice of validating HPLC/UPLC methodology is preferred but not essential
• Good understanding of GMP
• Knowledge of Analytical Chemistry and its practical application in a non-academic setting
• Understanding of basic statistics
• Computer literate, familiar with Microsoft Word and Excel
• Good communication skills
• Good organisational, interpersonal, and time management skills
• Enthusiastic, Flexible, Conscientious and Proactive approach
• To work efficiently with supervision or unsupervised as required
• Take a positive approach to own training
• Good decision making and problem-solving skills
• Demonstrate concern for safety and GMP when carrying out work

Qualifications

A relevant science degree is preferable, in conjunction with the skills/experience requirements listed above.

Working Pattern (12 month contract to start)

Contracted for a maximum of 37.5hrs, Mon – Fri., with some flexi-time. Optional overtime as and when required in line with business needs.

Technical Admin Support – Pharmaceutical R&D

To support the efficient operation of the R&D department by technical support to key R&D electronic applications and oversee the R&D stability sample management processes.

Key tasks:

1.Electronic Application support, which would require accurate administration of:

• R&D LIMS (Laboratory Information Management System), including the management, creation and amendment of system templates.
• Laboratory workflow systems, managing systems access and training of new personnel in the use of the system.
• The document management system, including acting as the department librarian for all controlled documents.
• Processing and routing documents for approval and monitoring systems to ensure compliance.
• The time recording system, managing systems access, allocating staff to projects and the creation/closure of projects.
• Archiving/file maintenance of controlled logbook documentation in accordance with SOPs
• R&D environmental datalogger records, including data for compliance, trends, and spotting potential issues to avoid non-compliances.

2. R&D Stability Sample Management:

• Dealing with the scheduling of sample pulls from storage and any returns; overseeing stability chamber capacity; initiating and managing mechanisms for deviations from SOPs, including QIRs, SENs, liaising with the necessary groups, including Quality to ensure satisfactory completions. Administrate the electronic applications that facilitate the above.
• This element will require liaison with a number of R&D groups to ensure an efficient use of resources and to help the team meet objectives.

Key requirements:

• Graduate Level or equivalent education, or relevant experience.
• Familiar and competent in use of standard ‘office’ applications (MS Word, Excel, Outlook, Internet Explorer).
• Competent in the use of technical applications, such as document management systems, LIMS, Chromatography systems.
• Experience of working in a regulated business, including working with SOPs, specifications etc.

Experience of similar work for a pharmaceutical company is preferred but not essential

12 Month contract to start.  37.5 hour week, Mon-Fri, flexi-time available

R&D Lab Services Stability /Tech Support Role

To support the efficient operation of the R&D department by technical support to key R&D electronic applications and oversee the R&D stability sample management processes.

Key tasks:

1.Electronic Application support, which would require accurate administration of:

• R&D LIMS (Laboratory Information Management System), including the management, creation and amendment of system templates.
• Laboratory workflow systems, managing systems access and training of new personnel in the use of the system.
• The document management system, including acting as the department librarian for all controlled documents.
• Processing and routing documents for approval and monitoring systems to ensure compliance.
• The time recording system, managing systems access, allocating staff to projects and the creation/closure of projects.
• Archiving/file maintenance of controlled logbook documentation in accordance with SOPs
• R&D environmental datalogger records, including data for compliance, trends, and spotting potential issues to avoid non-compliances.

2. R&D Stability Sample Management:

• Dealing with the scheduling of sample pulls from storage and any returns; overseeing stability chamber capacity; initiating and managing mechanisms for deviations from SOPs, including QIRs, SENs, liaising with the necessary groups, including Quality to ensure satisfactory completions. Administrate the electronic applications that facilitate the above.
• This element will require liaison with a number of R&D groups to ensure an efficient use of resources and to help the team meet objectives.

Key requirements:

• Graduate Level or equivalent education, or relevant experience.
• Familiar and competent in use of standard ‘office’ applications (MS Word, Excel, Outlook, Internet Explorer).
• Competent in the use of technical applications, such as document management systems, LIMS, Chromatography systems.
• Experience of working in a regulated business, including working with SOPs, specifications etc.

Experience of similar work for a pharmaceutical company is preferred but not essential

12 Month contract to start

37.5 hour week, Mon-Fri, flexi-time available

Laboratory Technician – Temporary

Are you a Laboratory Technician with a Mechanical Engineering background? If so, we'd love to hear from you!

Job seekers…

Are you looking for work?

It’s more challenging at the moment, but we’re still really keen to hear from you!  We’re continuing to register job seekers…just in a different way.

Instead of popping in to see us, email us a copy of your CV to jobs@gill-cooke.co.uk and we will arrange for one of our team to contact you about roles we currently have or to register your details for future opportunities.

Our consultants are now working remotely, but still working really hard behind the scenes to find all our candidates work.