Job summary
The pharmacy manufacturing unit is a busy licensed unit manufacturing Non Sterile and Sterile batches and extemporaneous products for use within the trust and externally.
This vacancy is to assist with the smooth running of the production unit, ensuring medicines are made fit for purpose under GMP. To lead and manage production staff, lead in production planning and liaise with a number of different departments.
We would like to hear from you if your background, experience, and skills include:
Experience as a Technician in pharmaceutical manufacturing or similar regulated environment
The ability to work within GMP principles, Health & Safety regulations and follow procedures
You are self-motivated with a proactive attitude
Would like to learn and develop your skills
Have a continuous improvement mind set
Excellent verbal and written communication skills - as you will need to follow detailed written instructions and record and process complete manufacturing records accurately
Good numeracy skills as you will need to complete simple mathematical calculations
Able to work alone or in a team
Main duties of the job
- Undertake supervision of batch manufacture ensuring all GMP and local procedures are followed.
- Assist the Principal Technician and Senior Production staff in the management of operational staff within PMU.
- Ensure any quality exceptions related to manufacturing are escalated and managed appropriately.
- Assist Senior Production staff with Production planning activities and scheduling batch manufacture.
- Deputise for the Principle Production Technician as required.
About us
Guys and St Thomas' NHS Foundation Trust has a number of pharmaceutical manufacturing units based cross site operating under MHRA and unlicensed controls.
Job description
Job responsibilities
- To undertake supervision of Sterile & Non-sterile batch manufacture and Extemp preparation ensuring all GMP and local procedures are followed.
- To ensure the Clean room environment if fit for use before any manufacturing activity is undertaken.
- To be responsible for the correct use and maintenance of complex manufacturing equipment such as the autoclave, ROTA machine, tablet machine and various mixing vessels.
- To liaise with the Quality Control and Quality Assurance departments over quality matters such as in-process controls and environmental monitoring.
- To work with the raw materials controller in maintain adequate stock levels of raw materials and consumables. To highlight and supervise any ordering of materials.
- To complete the autoclave cycle approvals following each sterilisation cycle performed during batch manufacture and to review and sign-off the Autoclave Daily Checks logs at the end of each week when operating in the Sterile area.
- To undertake the preparation and processing of material required for research or clinical trials.
- To ensure that all documentation associated with production is completed correctly, processed and filed in the correct place, including product documentation.
- Ensure daily checklists for utilities and services are fully completed at the end of each day. Escalating any issues to the Principal Technician.
- To be responsible for generating weekly production plans.
- To undertake routine inspection of manufacturing areas to ensure the areas are maintained to required standards.
- To undertake other manufacturing duties when required as deemed appropriate by the PMU Chief Technician.
Qualification and Validation
- To assist the Senior Production Staff in the assessment of new and replacement pieces of equipment.
- To be involved with the development of equipment protocols and validation to ensure suitability before being put into use.
- Take the lead on writing new procedures and ensuring a suitable training plan for the production team in use of new pieces of kit.
- To assist the pharmacy engineer in ensuring that regular maintenance of equipment such as the autoclaves is performed and appropriate documentation is processed and filed correctly.
Quality Management
- To assist the Senior Production staff with maintenance of the Pharmaceutical Quality System for the Production Unit.
- To complete quality deviation reports and assist with risk assessments.
- To assist the Senior Production Specialists with Root Cause Analysis and implementation of appropriate Corrective and Preventative Actions.
- To assist in the development and of control GMP documentation such as standard operating procedures, Activity Competency Records (ACRs), Batch manufacture records and validation documents
Staff Management
- To be responsible for the day to day management and allocation of all technical staff within the Pharmacy Manufacturing Unit.
- To lead at the Production daily huddles with appropriate reallocation of resource as needed and escalation of issues appropriately
- Ensure all operational staff are deemed competent, through accreditation, to perform manufacture activities, with routine checks on staff training portfolios and undertaking annual re validation activities.
- To be responsible for annual leave approval for operational staff within production.
- To have oversight of operational staff sickness and escalate any breach according to local policies.
- To assist the Chief Technician with performance management of operational staff.
- To have oversight of the production workload and escalate any capacity issues which cannot be worked around.
- To manage the domestic daily and monthly cleaning program to ensure the cleans are completed at the appropriate time and by suitably trained staff.
- To lead on annual revalidation of domestic staff and work with the Raw Materials controller to ensure continued supply of cleaning products.
- To assist in recruitment and selection of staff within the PMU.
- To be responsible for training of new operational staff by way of generating training plans and ensuring training is completed in an acceptable time frame.
- To participate in conducting Performance Development reviews for operational staff.
Job description
Job responsibilities
- To undertake supervision of Sterile & Non-sterile batch manufacture and Extemp preparation ensuring all GMP and local procedures are followed.
- To ensure the Clean room environment if fit for use before any manufacturing activity is undertaken.
- To be responsible for the correct use and maintenance of complex manufacturing equipment such as the autoclave, ROTA machine, tablet machine and various mixing vessels.
- To liaise with the Quality Control and Quality Assurance departments over quality matters such as in-process controls and environmental monitoring.
- To work with the raw materials controller in maintain adequate stock levels of raw materials and consumables. To highlight and supervise any ordering of materials.
- To complete the autoclave cycle approvals following each sterilisation cycle performed during batch manufacture and to review and sign-off the Autoclave Daily Checks logs at the end of each week when operating in the Sterile area.
- To undertake the preparation and processing of material required for research or clinical trials.
- To ensure that all documentation associated with production is completed correctly, processed and filed in the correct place, including product documentation.
- Ensure daily checklists for utilities and services are fully completed at the end of each day. Escalating any issues to the Principal Technician.
- To be responsible for generating weekly production plans.
- To undertake routine inspection of manufacturing areas to ensure the areas are maintained to required standards.
- To undertake other manufacturing duties when required as deemed appropriate by the PMU Chief Technician.
Qualification and Validation
- To assist the Senior Production Staff in the assessment of new and replacement pieces of equipment.
- To be involved with the development of equipment protocols and validation to ensure suitability before being put into use.
- Take the lead on writing new procedures and ensuring a suitable training plan for the production team in use of new pieces of kit.
- To assist the pharmacy engineer in ensuring that regular maintenance of equipment such as the autoclaves is performed and appropriate documentation is processed and filed correctly.
Quality Management
- To assist the Senior Production staff with maintenance of the Pharmaceutical Quality System for the Production Unit.
- To complete quality deviation reports and assist with risk assessments.
- To assist the Senior Production Specialists with Root Cause Analysis and implementation of appropriate Corrective and Preventative Actions.
- To assist in the development and of control GMP documentation such as standard operating procedures, Activity Competency Records (ACRs), Batch manufacture records and validation documents
Staff Management
- To be responsible for the day to day management and allocation of all technical staff within the Pharmacy Manufacturing Unit.
- To lead at the Production daily huddles with appropriate reallocation of resource as needed and escalation of issues appropriately
- Ensure all operational staff are deemed competent, through accreditation, to perform manufacture activities, with routine checks on staff training portfolios and undertaking annual re validation activities.
- To be responsible for annual leave approval for operational staff within production.
- To have oversight of operational staff sickness and escalate any breach according to local policies.
- To assist the Chief Technician with performance management of operational staff.
- To have oversight of the production workload and escalate any capacity issues which cannot be worked around.
- To manage the domestic daily and monthly cleaning program to ensure the cleans are completed at the appropriate time and by suitably trained staff.
- To lead on annual revalidation of domestic staff and work with the Raw Materials controller to ensure continued supply of cleaning products.
- To assist in recruitment and selection of staff within the PMU.
- To be responsible for training of new operational staff by way of generating training plans and ensuring training is completed in an acceptable time frame.
- To participate in conducting Performance Development reviews for operational staff.
Person Specification
Qualifications
Essential
- Accredited training for pharmaceutical production to diploma / BTEC level or equivalent, gained through experience.
Desirable
- NVQ Pharmacy Services Level 3- optional units: relevant to pharmacy practice area or equivalent
Previous Experience
Essential
- Previous experience of working in a GMP manufacturing environment producing a variety of pharmaceutical dosage forms.
- Previous evaluated experience of delivering induction and competency-based training.
- Previous evaluated experience of supervising staff and workload on a day-to-day basis
Desirable
- Previous experience of sterile batch manufacture
- Demonstrate experience of ability to appraise staff and set performance objectives
- Previous evaluated experience of recruitment and selection of staff
SKills and Knowledge
Essential
- Ability to clearly and accurately complete GMP monitoring documents.
- Demonstrated ability to work under pressure accurately.
- Demonstrated ability to clearly and accurately complete complex routine and non-routine documentation.
- Demonstrated good manual dexterity to undertake fine and accurate manipulative work
Person Specification
Qualifications
Essential
- Accredited training for pharmaceutical production to diploma / BTEC level or equivalent, gained through experience.
Desirable
- NVQ Pharmacy Services Level 3- optional units: relevant to pharmacy practice area or equivalent
Previous Experience
Essential
- Previous experience of working in a GMP manufacturing environment producing a variety of pharmaceutical dosage forms.
- Previous evaluated experience of delivering induction and competency-based training.
- Previous evaluated experience of supervising staff and workload on a day-to-day basis
Desirable
- Previous experience of sterile batch manufacture
- Demonstrate experience of ability to appraise staff and set performance objectives
- Previous evaluated experience of recruitment and selection of staff
SKills and Knowledge
Essential
- Ability to clearly and accurately complete GMP monitoring documents.
- Demonstrated ability to work under pressure accurately.
- Demonstrated ability to clearly and accurately complete complex routine and non-routine documentation.
- Demonstrated good manual dexterity to undertake fine and accurate manipulative work
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).
