Amit Mistry Email & Phone Number

Milton Keynes, England, United Kingdom

Ensure that all current Good Manufacturing Practice (GMP) Quality Assurance activities are effectively managed to meet agreed Trust and Pharmacy Department objectives whilst complying will all relevant national and local legislation, regulations and guidelines in relation to GMP. Responsible for leading the implementing and maintaining of a Pharmaceutical Quality Management (PQS) System across all relevant areas of Pharmacy and monitor its effectiveness. Providing expert quality assurance to the Pharmacy Aseptic Services Unit (PASU) in the quality review of their products and processes to maintain a high quality pharmaceutical aseptic service.Delivery of a safe and efficient Aseptic Services Unit which meets all legal and professional standards. Facilitate and support the efficient and cost effective use of medicines across Cancer and Aseptic Services. Contribute to enhancing patient safety and ensuring a positive patient experience for all patients across Cancer and Aseptics.

Milton Keynes, England, United Kingdom

Responsibility for managing all technical and operational aspects within the Aseptic Services department.In collaboration with the Aseptic Services Accountable Pharmacist and Clinical Director for Pharmacy, to provide the overall planning, strategic development and leadership of the service.Leading, developing, delivering and evaluating the service to both internal and external customers, in line with pharmacy service level agreements and objectives set.To manage the human resource issues for all non-pharmacist staff within the Aseptic Services Department.In collaboration with the Aseptic Services Accountable Pharmacist and the support of the Speciality Pharmacists (Oncology/ Haematology and Trials) develop, deliver and evaluate the technical and operational aspects of the aseptic services.To ensure that the highest standards of operation are continuously delivered by the development, implementation and monitoring of operational policies and procedures.To operate under the supervision of the Aseptic Services Accountable Pharmacist to organise and supervise the work of pharmacists, technicians and assistants.To ensure compliance at all times to clinical governance within area of responsibility.To act as NVQ assessor for Pharmacy Services Level 2 and 3.To ensure and supervise the safe handling of cytotoxic, hazardous and toxic materials.

Named as the “Production Manager” on the MHRA MIA (IMP) licence.Providing management oversight for MAC Clinical Research GMP / Pharmacy. Fully aseptically trained with over 15 years NHS/industry experience manufacturing injections, intravenous products, intrathecal as well as carrying out open process aseptic filling. Involved in validations and preparation of filter sterilised products.Manage and lead the GMP / Pharmacy sites comply to current regulations including GCP and GMP regarding drug receipt, dispensing / preparation, manufacture, packing, labelling, storage, accountability and return of Investigational Medicinal Product (IMP) / commercial and comparator and other non-IMP required for studies taking place at MAC Clinical Research.Primary liaison with sponsors, clients, and customers for GMP / Pharmacy queries.Leadership and Management• Assist with development and/or maintenance of facilities and processes to ensure preparation and dispensing of investigational compounds is performed to the appropriate standards.• Project Management of Study timelines, assignment and organisation of tasks to ensure timely delivery of First Patient First DoseQuality Management Systems• Ensure actions arising from quality events, change controls, risk assessments, self-inspections and audits are completed in a timely manner.• Assisting in leading regulatory inspections and Sponsor audits.• Maintain in depth knowledge of current regulatory requirements for clinical trial supplies and GMP standards Commercial• Identify new product ideas and development strategies which meet the needs of clients. • Support the development of pricing and marketing strategies.• Assist in the commercial development of MAC GMP / Pharmacy offering

Leeds, England, United Kingdom

Named as the “Production Manager” on the MHRA MIA (IMP) licence.To be responsible for the leading, delivery and evaluation of comprehensive production services including aseptic services.Responsible for training of production staff.To liaise with the Medical Director, PI (Principal Investigator), Sub- Investigators, Site Directors, Project Managers and CTAs, regarding requirements for studies of Investigational Medicinal Product (IMP).To liaise with sponsors, vendors and customers for pharmacy production queries. Ensure compliance of Manufacturing Unit with EU GMP.Ensure that products are produced and stored according to the appropriate documentation so that they reach the appropriate standards of quality.Approving the instructions relating to production operations and ensure their strict implementation.Ensuring that production records are evaluated and signed by an authorised person before they are sent to Quality Control (QC) Department.Checking the maintenance of their department, premises and equipment.Ensuring that the appropriate equipment and process validations are carried out to GMP standards.Ensuring that the required initial and continuing training of their department personnel is carried out.Authorisation of written procedures and other documents.The monitoring and control of the manufacturing environment.The approval and monitoring of contract manufacturers and providers of other GMP related outsourced activities.The designation and monitoring of storage condition of materials and products.The monitoring of compliance with the requirements of good manufacturing practiceParticipation in management reviews of processes performance, product quality and of the quality management system and advocating continual improvementWorking to the requirements of SI 2004 no 1031 and amendments thereof, which includes Good Clinical Practice.Work according to current data protection standards and practice good information management.

Leeds, England, United Kingdom

Completed a Postgraduate in Pharmaceutical Technology and Quality Assurance at the University of Manchester in 2020 as part of my personal and professional development.This course has advanced my quality assurance, quality control and technical skills to be a better leader, manager and technician. This has directly fed into my role which involves the training and development of new and existing members of staff.Management of two very busy Aseptic Pharmacy departments.Have been involved in rotas for members of staff; this takes into account skill mix, competency, optimum staff for required work and to ensure any training needs are met.Lead on training and development for the workforce; includes the creation of a training package alongside learning material and underpinning knowledge to reinforce the importance of the job role. This has started to build a solid foundation of learning for the department and many areas of ambiguity have been addressed or are in the process of being addressed. This has been done by creating standard operating procedures, checklists, protocols and schedules.Involved in optimising the workflow to ensure all intravenous medicines are delivered to the correct patient, at the correct dose at the correct time. Ensuring a high quality service for the production of CIVAS, adult and paediatric chemotherapy, adult and paediatric total parenteral nutrition and intrathecal chemotherapy.Having a responsibility to ensure that all products leaving the department are fit for their intended purpose.Fully broth tested and competent in all manufacturing areas.Involved in line management of a number of staff members; this includes training, reviews, personal development plans and supporting performance management. This also includes managing a large workforce who I don’t directly line manage. Involved in recruitment and selection for the department; which I take into account succession planning for the future.

Leeds, England, United Kingdom

Working in a variety of fast paced, diverse environments such as St. James University Hospital, Leeds, Bexley Wing Oncology Dispensary, Bexley Wing Aseptics and Leeds General Infirmary Aspetics. My experience also spans a number of inpatient and out patient dispensaries and a ward support role during my student pharmacy technician post. A number of years aseptic experience of manufacturing from CIVAS, Chemotherapy and Total Parental Nutrition (both adult and paediatric). Knowledge about the ICH & orange guide, including principles about Good Manufacturing Practice (GMP, GLP). Excellent understanding about Clinical Trials, testing & procedures (GCP). This knowledge helps me to have an insight into the various types of dispensing, standard operating procedures, ordering methods, dates of clinics and familiarity of the types of prescriptions. I also fully appreciated and have awareness of the various types microcrobial testing which is carried out on a regular basis to ensure the quality and safety of the products and service provided by our pharmacy. Another skill I have is being an accuracy checker, looking to add the accuracy checking NVQ/QCF unit to my qualifications as part of my CPD.Can dispense a variety of prescriptions including inpatient, outpatient, unlicensed orders, oncology and clinical trials and control drug requisitions. Counselling medication to patient’s regardless of their requirements, I can adapt to each patient individually. Medications included oncology, antibiotics, eye drops, inhaler technique, gastrointestinal medication and many more.Very familiar with the JAC computer system and its various programme options

Leeds, England, United Kingdom

I have rotated around a number of dispensaries, which included Inpatient, Outpatient and Aseptic Pharmacies within St. James Hospital and the Leeds General Infirmary. Dispensed non-stock orders for patients, Electronic-Discharge Advice Notes, control drug prescriptions for a variety of wards and a range of hospital clinics. Have gained a variety of skills such as counselling patients, dispensing prescriptions, dealing with queries both face to face, over the phone and via email. I have experience working within an unlicensed Aseptic Pharmacy manufacturing department. I have extensive knowledge and skills to write up orders and to formulate CIVAS, Chemotherapy and Total Parental Nutritional products. I have had experience working on a Respiratory and Elderly Hospital ward as a Medicines Management Technician. I further developed my communication skills with patients and also developed my medical knowledge about why medicines are prescribed. I was involved in looking at drug charts and assisting the Pharmacy Technician in ordering medicines for patients and to organise the discharge medicines of a patient.Having been on rotation within 2 different Outpatient Pharmacies, I dispensed various types of medication such as tablets, inhalers, topical, oral solutions, unlicensed medicine, sachets etc. I was also involved in taking in prescriptions from patients, checking to ensure they have filled in their declarations if necessary. I was also keen at asking the patient's to confirm their details, checking which clinic they have been to and also checking if they were allergic to anything (medical and non medical) and taking payments from patient's.I have developed a great deal confidence in counselling patients on a variety of medication and believe that I can firmly work within the limits of my job role. I know when to refer a problem to a Pharmacist and also know where to look for information relating to medication (BNF, Martindale, EMC, NEWT Guidelines).

Leeds, England, United Kingdom

Working in the Pharmacy Aseptics department involves, stock control, labelling (using the Pharmacy JAC system), assembly, preparation, dispensing, receipt and distribution of pharmaceuticals. IIncludes setting trays and manufacturing various pharmaceuticals ranging from CIVAS (Central Intravenous Additive Service), Chemotherapy and TPN (Total Parental Nutrition of Adults and Paediatric). Knowledge about the ICH & orange guide, including principles about Good Manufacturing Practice (GMP, GLP). Knowledge about Clinical Trials, testing & procedures (GCP).

Liverpool, England, United Kingdom

Worked on a project title 'The Analysis of Selenium Species in OTC Medicine using ICP-MS.Working on an ICP-MS with PlasmaLab software to analyse the amount of selenium present in over the counter medicine, Setting the instrument up to its maximum sensitivity. Preparing standards to make calibration graphs for the instrument. Using aqua regia in acid relfux and microwave techniques in order to digest the tablets. Worked on quantifying the amount of magnesium in magnesium stearate tablets, using an ashing technique in a furnace. Prepared a report of my findings.

Pharmaceutical Technology And Quality Assurance, Pass

Foundations of PTQA Radiopharmacy Formulation Sciences Aseptics Quality Control Clinical Trials Advanced Aseptics

Postgraduate Radiopharmacy Course, Radiopharmacy, Pass

Btec Level 4 Professional Diploma In Aseptic Services, Pharmacy Aseptic Services

Medicines legislation and professional practice in aseptics Introduction to Pharmaceutical Microbiology Theory and Practice of aseptic.

Btec Level 3 Diploma In Pharmaceutical Science

Bachelor Of Science (Bsc) (Hons), Pharmaceutical Science And Clinical Research