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Quality Assurance Technician
To undertake routine clerical and analytical work for Good Laboratory Practice in the QA Department, to implement validation protocols and to assist with the environmental monitoring of the Specials licensed MHRA Medicines and Healthcare products Regulatory Agency) units, CIVAS (Central Intravenous Additive Service) and Radiopharmacy units.
QUALIFICATIONS/SPECIAL TRAINING :
BTEC Level 3 Diploma in Applied Science or equivalent.
BSc in Chemistry or Biological Sciences or equivalent
IT Literate with basic Word and Excel skills
Working knowledge of GMP (Good Manufacturing Practice and GLP (Good Laboratory Practice)
Good attention to detail
Good communication skills
Analytical laboratory work
Implementation of Validation Protocols
Presenting and reporting data
Quality management standards
Adaptable and enthusiastic
Good communication skills
Good social skills
Ability to travel between multiple sites at short notice under own steam
• Assist in the provision of clinical technical service through analysis of environmental and microbiological reporting.
• Ability to problem solve. This requires a broad range of pharmaceutical knowledge and flexibility which can have an impact on clinical treatments provided by the Organisation Aseptic unit.
• Assist the Maintenance Lead with coordinating equipment and facilities servicing and repairs.
• Evaluate environmental and sample testing data and submit reports.
• Preparation of reagents, analytical solutions and other materials as required for use in the QC laboratory.
• Maintain quality related documentation in compliance with GMP standard
• Evaluate environmental monitoring samples and report results to the Manufacturing, Repackaging, CIVAS and Radiopharmacy Units.
• Update and write standard operating procedures for activities relevant to the role.
• Good housekeeping of the QC laboratory in accordance with GLP standards, with responsibility for cleanliness and tidiness of laboratory and equipment
• Carry out other designated testing procedures as required.
• Participate in training students, pre-reg pharmacists and other staff assigned to work in the QC Department.
KEY RESULT AREAS/PRINCIPAL DUTIES AND RESPONSIBILITIES
• Implement validation protocols for Manufacturing, Repackaging, CIVAS and Radiopharmacy Units
• Perform analytical instrumental analysis and chemical analysis to support Manufacturing Unit as required.
• Assist the Quality Assurance Manager in the implementation of any new techniques or work patterns.
• Work under the departmental Quality System to ensure continuous process and product improvement.
• Update COSHH documentation for products handled within the Pharmacy Department.
• Ability to work unsupervised. The post holder will be expected to decide on the best way to utilise their time and the resources available in carrying out work instructions, validation protocols and laboratory procedures while ensuring that these are completed to the required time and standards as agreed to by Quality Assurance Manager and defined by regulatory guidance.
• Undertake other reasonable duties as required, appropriate to grading.
• The post holder is expected to comply with Organisation Infection Control Policies and conduct him/herself at all times in such a manner as to minimise the risk of healthcare associated infection.
NB: The Quality Assurance Technician may not dispense medicines, manufacture products or give advice on the use of drugs unless trained as pharmaceutical technician.
Other duties and Responsibilities-Quality Assurance Technician
• To participate in other duties appropriate to grade at the request of the relevant manager.
• To participate in flexible working arrangements including late duties, weekends, bank holidays and on call as appropriate.
• To take part in regular performance appraisal.
• To undertake any training required in order to maintain competency including mandatory training, i.e. Fire, Manual Handling.
• To contribute to and work within a safe working environment.