Careers at #LNWH
London North West University Healthcare NHS Trust (LNWH)
cares for the people of Brent, Ealing, Harrow and beyond.
Our team of more than 8,200 clinical and support staff serve a diverse population of almost one million people.
We run major acute services at: Northwick Park Hospital: home to one of the busiest emergency departments (A&E) in the country. The hospital provides a full range of services including the country's top-rated hyper-acute stroke unit and one of only three hyper-acute rehabilitation units in the UK. St Mark's Hospital: an internationally renowned specialist centre for bowel disease. Ealing Hospital: a busy district general hospital providing a range of clinical services, as well as a 24/7 emergency department and urgent care centre, and specialist care at Meadow House Hospice. Central Middlesex Hospital: our planned care site, hosting a range of surgical and outpatient services and collocated with an urgent care centre. We are a university teaching NHS trust, in recognition of the important role we play in training clinicians of the future and bringing the benefits of research to the public.
Job Overview
This post is to provide direct support to the Quality Department in the management of the day-to-day aspects of the Quality Control Laboratory to ensure adherence to established quality standards. The Quality control section of Pharmacy Technical Services (PTS) Department is responsible to confirm pharmaceutical products are manufactured to GMP requirements and fully tested to release specification in line with all relevant regulatory standards to safeguard product quality and patient safety.
Main Duties of the Job
Analysis, interpretation and reporting of test results of a wide range of raw materials, packaging materials, intermediates bulk and finished products as required. To supervise and direct all these activities as needed. To undertake and supervise stability studies - microbiological and analytical method development and validation (ICHQ2 (R1)) of new formulations and existing products. Responsible for the establishment, maintenance and review of the documents supporting the Pharmaceutical Quality System (PQS). These documents include policies, standard operating procedures, protocols, worksheets, equipment maintenance records including planned preventative maintenance, full records of testing of all starting materials, packaging materials, intermediates and finished products as agreed in the PQS. To ensure timely closure of incident logs, deviations, change controls, MER's (Microbial excursion reports) and CAPAs by carrying out tasks as agreed and providing evidence for the same. To carry out laboratory investigation and root cause analysis as needed. Provide support and direction to QC analysts and ensure review/closure of MER's and LIR's on time. Comply with data integrity policy and procedure. Provision of microbiological trend analysis reports and potential improvements. To act as a releasing officer for pre-pack over labelled products manufactured under MHRA 'Specials' licence. Person Specification
Education/Qualifications Essential Criteria BSc degree in Chemistry, Pharmaceutical Science or relevant scientific discipline. Desirable Criteria Post graduate qualification. Knowledge & Experience Essential Criteria Minimum of 5 years laboratory experience in hospital or industry linked to a manufacturing unit. Knowledgeable in different microbiological and laboratory instrumentation techniques i.e. HPLC, ICAP, UV/VIS, IR Spectroscopy, Polarimetry, Refractometry etc. Demonstrated ability to identify problems, analyse root cause and propose solutions. Experience of working to Pharmacopoeial methods and specifications. Knowledge and experience of compliance to MHRA GxP Data Integrity guidance. Knowledgeable in environmental monitoring of clean rooms. Desirable Criteria Post graduate qualification. Knowledgeable in microbiological method validation, gram staining and microbiological identification testing. Employer Certification / Accreditation Badges
Documents to Download Principal QC Analyst - Microbiology JD (PDF, 344.4KB) Guidance for applying (PDF, 914.7KB) What makes us Special - Mobile friendly version (PDF, 379.0KB) What makes us special? (PDF, 891.8KB) HEART values (PDF, 158.5KB)
#J-18808-Ljbffr
London North West University Healthcare NHS Trust (LNWH)
cares for the people of Brent, Ealing, Harrow and beyond.
Our team of more than 8,200 clinical and support staff serve a diverse population of almost one million people.
We run major acute services at: Northwick Park Hospital: home to one of the busiest emergency departments (A&E) in the country. The hospital provides a full range of services including the country's top-rated hyper-acute stroke unit and one of only three hyper-acute rehabilitation units in the UK. St Mark's Hospital: an internationally renowned specialist centre for bowel disease. Ealing Hospital: a busy district general hospital providing a range of clinical services, as well as a 24/7 emergency department and urgent care centre, and specialist care at Meadow House Hospice. Central Middlesex Hospital: our planned care site, hosting a range of surgical and outpatient services and collocated with an urgent care centre. We are a university teaching NHS trust, in recognition of the important role we play in training clinicians of the future and bringing the benefits of research to the public.
Job Overview
This post is to provide direct support to the Quality Department in the management of the day-to-day aspects of the Quality Control Laboratory to ensure adherence to established quality standards. The Quality control section of Pharmacy Technical Services (PTS) Department is responsible to confirm pharmaceutical products are manufactured to GMP requirements and fully tested to release specification in line with all relevant regulatory standards to safeguard product quality and patient safety.
Main Duties of the Job
Analysis, interpretation and reporting of test results of a wide range of raw materials, packaging materials, intermediates bulk and finished products as required. To supervise and direct all these activities as needed. To undertake and supervise stability studies - microbiological and analytical method development and validation (ICHQ2 (R1)) of new formulations and existing products. Responsible for the establishment, maintenance and review of the documents supporting the Pharmaceutical Quality System (PQS). These documents include policies, standard operating procedures, protocols, worksheets, equipment maintenance records including planned preventative maintenance, full records of testing of all starting materials, packaging materials, intermediates and finished products as agreed in the PQS. To ensure timely closure of incident logs, deviations, change controls, MER's (Microbial excursion reports) and CAPAs by carrying out tasks as agreed and providing evidence for the same. To carry out laboratory investigation and root cause analysis as needed. Provide support and direction to QC analysts and ensure review/closure of MER's and LIR's on time. Comply with data integrity policy and procedure. Provision of microbiological trend analysis reports and potential improvements. To act as a releasing officer for pre-pack over labelled products manufactured under MHRA 'Specials' licence. Person Specification
Education/Qualifications Essential Criteria BSc degree in Chemistry, Pharmaceutical Science or relevant scientific discipline. Desirable Criteria Post graduate qualification. Knowledge & Experience Essential Criteria Minimum of 5 years laboratory experience in hospital or industry linked to a manufacturing unit. Knowledgeable in different microbiological and laboratory instrumentation techniques i.e. HPLC, ICAP, UV/VIS, IR Spectroscopy, Polarimetry, Refractometry etc. Demonstrated ability to identify problems, analyse root cause and propose solutions. Experience of working to Pharmacopoeial methods and specifications. Knowledge and experience of compliance to MHRA GxP Data Integrity guidance. Knowledgeable in environmental monitoring of clean rooms. Desirable Criteria Post graduate qualification. Knowledgeable in microbiological method validation, gram staining and microbiological identification testing. Employer Certification / Accreditation Badges
Documents to Download Principal QC Analyst - Microbiology JD (PDF, 344.4KB) Guidance for applying (PDF, 914.7KB) What makes us Special - Mobile friendly version (PDF, 379.0KB) What makes us special? (PDF, 891.8KB) HEART values (PDF, 158.5KB)
#J-18808-Ljbffr
