
Quality Assurance Specialist- Aseptic & Radiopharmacy Services, Band 7
- Cheltenham, Gloucestershire
- £47,810-54,710 per year
- Permanent
- Full-time
- Degree (or equivalent) in chemistry, life science, pharmacy, other relevant scientific subject or Qualified Pharmacy technician with suitable experience
- Hold statutory professional registration or be eligible to register with relevant professional body (e.g. GPhC, HCPC, RSC, RBS) with knowledge of aseptic or radiopharmacy preparation or manufacturing services and quality control.
- Post graduate qualification (Diploma or MSc) in Pharmaceutical Technology/Quality Assurance (or equivalent qualification/experience). Diploma or MSc
- Knowledge in and implementation of Good Manufacturing Practice (GMP), ventilation (HTM-03) and NHS Quality Assurance of Aseptic Preparation Services (QAAPs)
- Knowledge in pharmaceutical quality assurance including radiopharmaceuticals
- The audit process - internal and external. Change Management - Good knowledge of Pharmaceutical Microbiology - Operational Management Risk Management - Validation Requirements for facilities, equipment and products
- Understanding of HTM 02-01: Medical gas pipeline systems Part A: Design, installation, validation and verification and HTM 02-01: Medical gas pipeline systems Part B:
- Experience Quality Assurance/Control Officer within a pharmaceutical manufacturing / preparation facility (or equivalent)
- Demonstrable experience in training staffs in quality assurance & quality control method
- Experience of input into the design, business case, development, commissioning and validation of production facilities.
- Experience as Quality Assurance/Control Officer within a Radiopharmacy facility
- Experience using QMS supporting software such as Q-Pulse, iPassPort
- People management including performance, disciplinary and sickness management
- Prioritization, time management, personal effectiveness, influencing, analytical and problem-solving skills of a consistently high standard maintaining attention to detail and accuracy.
- Innovation/implementation skills to develop services in accordance accepted with standards
- Excellent communication (written, oral, presentations) and interpersonal skills essential to exchange highly complex information to colleagues, patients and relatives, clinicians and senior managers (both within and outside of the trust). Ability to take complex ideas and communicates to all levels of the service
- Evidence of continuing self-development relevant to role
- Degree (or equivalent) in chemistry, life science, pharmacy, other relevant scientific subject or Qualified Pharmacy technician with suitable experience
- Hold statutory professional registration or be eligible to register with relevant professional body (e.g. GPhC, HCPC, RSC, RBS) with knowledge of aseptic or radiopharmacy preparation or manufacturing services and quality control.
- Post graduate qualification (Diploma or MSc) in Pharmaceutical Technology/Quality Assurance (or equivalent qualification/experience). Diploma or MSc
- Knowledge in and implementation of Good Manufacturing Practice (GMP), ventilation (HTM-03) and NHS Quality Assurance of Aseptic Preparation Services (QAAPs)
- Knowledge in pharmaceutical quality assurance including radiopharmaceuticals
- The audit process - internal and external. Change Management - Good knowledge of Pharmaceutical Microbiology - Operational Management Risk Management - Validation Requirements for facilities, equipment and products
- Understanding of HTM 02-01: Medical gas pipeline systems Part A: Design, installation, validation and verification and HTM 02-01: Medical gas pipeline systems Part B:
- Experience Quality Assurance/Control Officer within a pharmaceutical manufacturing / preparation facility (or equivalent)
- Demonstrable experience in training staffs in quality assurance & quality control method
- Experience of input into the design, business case, development, commissioning and validation of production facilities.
- Experience as Quality Assurance/Control Officer within a Radiopharmacy facility
- Experience using QMS supporting software such as Q-Pulse, iPassPort
- People management including performance, disciplinary and sickness management
- Prioritization, time management, personal effectiveness, influencing, analytical and problem-solving skills of a consistently high standard maintaining attention to detail and accuracy.
- Innovation/implementation skills to develop services in accordance accepted with standards
- Excellent communication (written, oral, presentations) and interpersonal skills essential to exchange highly complex information to colleagues, patients and relatives, clinicians and senior managers (both within and outside of the trust). Ability to take complex ideas and communicates to all levels of the service
- Evidence of continuing self-development relevant to role