Job summary
We are looking for an experienced analytical chemist / quality control analyst to join our quality control team at the Guys and St Thomas' manufacturing unit.
The laboratory provides an analytical testing and reporting service for the trust pharmaceutical manufacturing units and works closely with the quality assurance and production teams.
Analytical method validation experience is key for this role along with acting in a supervisory capacity.
Training will be given on completion of quality documents pertaining to the pharmaceutical quality system.
Please note this is a fixed term contract to cover maternity leave.
Main duties of the job
The key responsibilities for Senior QC Scientist include:
- To carry out all testing according to the approved Standard Operating Procedures (SOP) for Raw Material, Finished Products Specifications and Policies of the Department.
- Full Pharmacopeia testing of new Raw Material products according to the assessments.
- To carry out and document investigations including but not limited to Out of specifications, Deviations, Change controls as required by the Quality Control Manager.
- To be an active participant in the maintenance of the Quality Control laboratory Quality Management System.
- To undertake, after suitable training, sampling of booked in raw materials ready for QC testing.
- To carry out monthly calibration of balances
- Routine sampling and chemical testing of WFI / Lab water
About us
The Pharmacy Manufacturing Unit (PMU) at Guy's Hospital is an MHRA licensed unit, manufacturing a broad portfolio of Specials (unlicensed) medicines and extemporaneously prepared products. These include non-sterile oral liquids & suspensions, tablets, capsules, creams & ointments and terminally sterilized parenteral solutions, topical gels and eye drops. Additionally, under our MIA(IMP) License, the PMU provides clinical trial manufacturing activities through our collaboration with Kings Health Partners and other clinical trial organizations.
The Quality Control is part of the PMU, we provide analytical testing and also support other activities to other sections such as Production (Sterile & Non-Sterile), Aseptic and Quality Assurance.
Job description
Job responsibilities
Duties and Responsibilities:
- To carry out all testing according to the approved Standard Operating Procedures (SOP) for Raw Material, Finished Products Specifications and Policies of the Department. To make a judgement of the validity of the results produced by taking into account all relevant factors. To evaluate results and alert QC Manager or deputy of any out of specification results.
- Full Pharmacopeia testing of new Raw Material products according to the assessments.
- To maintain laboratory stocks of chemicals and reagents. To undertake preparation of reagents and standards using highly sensitive electronic balance, validated pipettes and Class A volumetric glassware. To check these using classical or instrumental methods according to the relevant SOP.
- To carry out and document investigations including but not limited to Out of specifications, Deviations, Change controls as required by the Quality Control Manager.
- To be an active participant in the maintenance of the Quality Control laboratory Quality Management System
- To undertake, after suitable training, sampling of booked in raw materials ready for QC testing.
- To undertake, after suitable training, testing of containers according to QC specification and worksheets.
- To carry out monthly calibration of balances
- Routine sampling and chemical testing of WFI / Lab water, according to the SOP.
- To write, review, execute protocols for analytical method and equipment validation/qualification as required.
- To execute finished product stability testing as required
- To use environmental monitoring and other QC equipment correctly by following the procedures for use, cleaning and monitoring of such equipment.
- To assist in the cleaning of glass wear and correct storage of cleaned glass wear with in the QC laboratory
- To undertake calibrations of QC equipment as required.
- Responsible for upkeep of equipment files and PPM database entries.
- Collate test data and generate reports to be submitted to QC Lab Manager. To notify the QC Lab Manager immediately of any Non-compliances to the testing protocol
- To ensure that working procedures at all times conform with standards of Good Laboratory Practice, The Health and Safety at Work Act, Control of Substances Hazardous to Health Regulations and other relevant legal and professional directives.
Operational
- To contact appropriate supervisor for assistance as required when undertaking the activities of this job description.
- To assist in the maintenance, upkeep and cleaning of the department as required and help in maintaining the general tidiness of the unit.
- To ensure all GMP documentation is completed, stored and maintained appropriately.
- To participate in the plans and schedules as provided for the laboratory in a constructive manner and help in the achievement of its objectives.
Other:
- To attend courses and undertake training to develop expertise in appropriate skills, where training needs are identified.
- To follow departmental and Trust procedures and policies.
- To undertake other duties as required in order to maintain the safe, efficient and effective provision of Quality services or as required to meet the department needs.
- To review QC Standard Operating Procedures on Q Pulse as allocated.
- To support the QC department in preparation for all audits Internal/Clients/MHRA.
- To review expired specifications for starting materials, finished products, packaging materials within the Quality Control Department as required.
- To provide clear communication within the team and other units.
- To write necessary documentation for the new equipment.
Job description
Job responsibilities
Duties and Responsibilities:
- To carry out all testing according to the approved Standard Operating Procedures (SOP) for Raw Material, Finished Products Specifications and Policies of the Department. To make a judgement of the validity of the results produced by taking into account all relevant factors. To evaluate results and alert QC Manager or deputy of any out of specification results.
- Full Pharmacopeia testing of new Raw Material products according to the assessments.
- To maintain laboratory stocks of chemicals and reagents. To undertake preparation of reagents and standards using highly sensitive electronic balance, validated pipettes and Class A volumetric glassware. To check these using classical or instrumental methods according to the relevant SOP.
- To carry out and document investigations including but not limited to Out of specifications, Deviations, Change controls as required by the Quality Control Manager.
- To be an active participant in the maintenance of the Quality Control laboratory Quality Management System
- To undertake, after suitable training, sampling of booked in raw materials ready for QC testing.
- To undertake, after suitable training, testing of containers according to QC specification and worksheets.
- To carry out monthly calibration of balances
- Routine sampling and chemical testing of WFI / Lab water, according to the SOP.
- To write, review, execute protocols for analytical method and equipment validation/qualification as required.
- To execute finished product stability testing as required
- To use environmental monitoring and other QC equipment correctly by following the procedures for use, cleaning and monitoring of such equipment.
- To assist in the cleaning of glass wear and correct storage of cleaned glass wear with in the QC laboratory
- To undertake calibrations of QC equipment as required.
- Responsible for upkeep of equipment files and PPM database entries.
- Collate test data and generate reports to be submitted to QC Lab Manager. To notify the QC Lab Manager immediately of any Non-compliances to the testing protocol
- To ensure that working procedures at all times conform with standards of Good Laboratory Practice, The Health and Safety at Work Act, Control of Substances Hazardous to Health Regulations and other relevant legal and professional directives.
Operational
- To contact appropriate supervisor for assistance as required when undertaking the activities of this job description.
- To assist in the maintenance, upkeep and cleaning of the department as required and help in maintaining the general tidiness of the unit.
- To ensure all GMP documentation is completed, stored and maintained appropriately.
- To participate in the plans and schedules as provided for the laboratory in a constructive manner and help in the achievement of its objectives.
Other:
- To attend courses and undertake training to develop expertise in appropriate skills, where training needs are identified.
- To follow departmental and Trust procedures and policies.
- To undertake other duties as required in order to maintain the safe, efficient and effective provision of Quality services or as required to meet the department needs.
- To review QC Standard Operating Procedures on Q Pulse as allocated.
- To support the QC department in preparation for all audits Internal/Clients/MHRA.
- To review expired specifications for starting materials, finished products, packaging materials within the Quality Control Department as required.
- To provide clear communication within the team and other units.
- To write necessary documentation for the new equipment.
Person Specification
Knowledge
Essential
- B.Sc Chemistry or related subject
Desirable
- Membership of Royal Society of Chemistry
Skills
Essential
- Demonstrate understanding of the principles of GMP/GLP and role of QC in Pharmaceutical Manufacturing environment.
- Demonstrated effective customer service skills
- Demonstrated understanding of the principles of GMP and QC in a manufacturing environment
- Demonstrated ability to accurately follow written and oral instructions
Desirable
- Demonstrated ability to use a computer
Experience
Essential
- 3 years post qualification experience in Quality Control in Hospital or Industrial environment.
- Experience of a range of Analytical Chemistry techniques
- Experience of managing and training staff
Person Specification
Knowledge
Essential
- B.Sc Chemistry or related subject
Desirable
- Membership of Royal Society of Chemistry
Skills
Essential
- Demonstrate understanding of the principles of GMP/GLP and role of QC in Pharmaceutical Manufacturing environment.
- Demonstrated effective customer service skills
- Demonstrated understanding of the principles of GMP and QC in a manufacturing environment
- Demonstrated ability to accurately follow written and oral instructions
Desirable
- Demonstrated ability to use a computer
Experience
Essential
- 3 years post qualification experience in Quality Control in Hospital or Industrial environment.
- Experience of a range of Analytical Chemistry techniques
- Experience of managing and training staff
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Additional information
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
