St. Albans, Hertfordshire, South East, United Kingdom
Evolve Selection Limited
Manager in the Process Engineering department. You will ensure that operations are performed in accordance with the requirements of company standards, industry standards, and GMP/GDP guidelines. Whats on offer? Excellent Salary & Benefits: You will receive compelling salary DOE, along with an exceptional benefits package. Innovative Leadership in Automation more »
Huntingdon, Cambridgeshire, East Anglia, United Kingdom
MM Flowers Ltd
monitoring goodmanufacturing practices, applying HACCP principles and preventing reoccurrence of non-conformance against these standards. To audit compliance against Quality Management Systems and GMP, raising all non-conformances against relevant standards with objective evidence enabling the operational teams to take the appropriate and necessary corrective action, to follow up more »
work environment and that all tools are maintained and accounted for. Liaise with the SHEQ team to resolve H&S issues, environmental, internal audits, GMP, COSHH and ISO quality issues, and ensure all compliance checks are complete and correctly filled. Attend all nominated training modules as necessary. Undertaking any other more »
Royston, Hertfordshire, South East, United Kingdom Hybrid / WFH Options
Sartorius Corporate Administration GmbH
development with an understanding of the product life cycle ideally in laboratory automation, or pharmaceutical manufacturing environment following ISO/IEC and/or GMP standards though candidates from other industries will also be considered Hands on experience in electrical engineering in prototyping, engineering, design and testing Working knowledge of more »
and vision systems integrated within packaging equipment including interfaces with enterprise systems. Responsible for providing cGMP compliant control systems as per GAMP5 and EU GMP Annex 11. Key Experience Essential - Practical experience working within manufacturing and packaging environments Experience of the automation project lifecycle including design, configuration, implementation, testing, commissioning more »
Royston, England, United Kingdom Hybrid / WFH Options
Sartorius Corporate Administration GmbH
development with an understanding of the product life cycle ideally in laboratory automation, or pharmaceutical manufacturing environment following ISO/IEC and/or GMP standards though candidates from other industries will also be considered Hands on experience in electrical engineering in prototyping, engineering, design and testing Working knowledge of more »
on a permanent basis. The Validation Manager will be leading the validation function to be able to execute report activities within the framework of GMP - Annex 11 & 15 in compliance with QMS requirements. In addition, they will be supporting multiple validation projects, liaising with the project departments and the associated more »
responsibility will be to ensure that all materials are tested according to agreed specifications and procedures, in agreed time frames and in accordance to GMP and company guidelines. Other key responsibilities will include to: - Qualify, maintain and calibrate all laboratory equipment according to procedures. - Maintain all laboratory Quality Systems and … Assurance Performance Indicators. Your Background: You are required to have the following qualifications, skills and experience: - Knowledge of Quality Control, Quality Assurance, Quality Systems, GMP and basic understanding of manufacture and packaging of pharmaceutical products. - Stability testing experience - Hands-on HPLC experience - Good technical and scientific judgement. - Diplomatic, self-motivating … professional with problem solving and decision-making capabilities. - Basic understanding of GMP Guidelines and Regulations. Apply: For more information, or to apply for this QC Analyst position please contact Hannah Oakley on 01246 457711 or email hoakley@ckgroup.co.uk. Please quote job reference 56706 in all correspondence. It is essential that more »
its capabilities. This will include ensuring activities associated with manufacturing and lab equipment, facilities, utilities, laboratory, and computer systems are completed, in accordance with GMP requirements Responsibilities : Manage a team and ensure validation master plans (VMPs), protocols and procedures are established To prepare and maintain validation plans (VPs) and identifying … protocols for equipment, facilities and utilities Your Background: Degree (or equivalent) in a Science or related discipline Qualifications related to validation and quality compliance (GMP/ICH/FDA/USP/EP policies). Experience of validating manufacturing/laboratory equipment, facilities/utilities and processes, including the generation more »
to provide high quality, synthetic DNA for use in gene therapy and gene editing platforms. The company is growing rapidly and is establishing a GMP gene synthesis hub at its site just north of Cambridge, UK to facilitate the scaling and optimisation of a proprietary DNA manufacturing process. As a … essential. Experience of working in cleanrooms and/or manufacturing environments is desirable. An understanding of Quality Control or concepts of GoodManufacturing Practices (GMP) Scrupulous attention to detail Comfortable working autonomously or collaboratively Methodical, organised, and able to prioritise work effectively Must hold the right to work in the more »
a Qualified Person to join our team at Harlow, UK. The successful person will perform the quality assurance activities and quality oversight of the GMP functions performed within Pharma R&D. As a Qualified Person, is personally accountable to conform to the legal regulatory requirements as stated in Clinical trials more »
installation and commissioning. 2. As the Automation Engineer, you will be responsible for the design and documentation review of Pharmaceutical equipment and adhering to GMP and GAMP 5 guidelines. 3. As the Automation Engineer, you will be responsible for executing and witnessing SAT, IQ/OQ/PQ. You will more »
engineering or similar. Substantial demonstrable experience leading a company through ISO9001/13485 relating to medical device instrumentation development and manufacture. Further exposure to GMP manufacture for biological products would be desirable. Comprehensive experience with "quality management" within a technology company including instilling a quality-focused culture and maintainable approach more »
least 3 years industrial experience and be able to work on a number of product development projects. Previous industrial experience within a regulated environment GMP environment, pharmaceuticals, food, electronics . Demonstrate project control, with evidence on how you achieved the business goal. Provide support to design operatives to aid in more »
Cambridge University Hospital NHS Foundation Trust
application of Standard Operating Procedures and Quality Assurance Systems. Health and Safety in the Workplace. Maintaining clean and hygienic work environments. GoodManufacturing Practise (GMP) and/or Good Distribution Practices (GDP). Knowledge of stock control systems. Desirable Aseptic dispensing and preparation. Pharmaceutical Science. Contamination Control Systems. Clinical trials more »
The site Head of Quality will lead the designated site in terms of GMDP quality and compliance, including in the areas of: QA, QC, GMP, GDP, QP activities and RP activities in line with the business goals and plan. Responsibilities: Establish clear and compliant GMDP standards for all site activities more »
experience leading IT at a senior management level • Track record of delivering results quickly • Experience in delivering IT services to customers • Work in a GMP or highly regulated environment Preferred Experience: • Experience of agile product development • Experience of Lean Six Sigma • Infrastructure delivery (networking, hardware) to customers • Experience with data more »
Comfortable operating autonomously once goals and objectives are set. Excellent interpersonal, written and verbal communication skills. Confidence and ambition to provide pragmatic and considered GMP advice. Having current and up to date professional knowledge, expertise and best practice. Proven ability to engage constructively with colleagues at all levels across different more »
to manage/adjust timelines and priorities; escalate issues and concerns as they arise. Ensure all activities are delivered compliant to defined processes and GMP; concerns/risks are identified. Ensure appropriate and complete records arising through operational activities are maintained and TPCs in compliance with GMP and that meet … commitments meet agreed timelines and quality KPIs. Interim Packaging Project Coordinator - The Skills You'll Need to Succeed: Experience working in an R&D GMP environment. Experience working in an operational Packaging Labelling Distribution (PLD) role within Clinical Trial Supplies. Knowledge of Clinical Trial Supply CMOs and their capabilities Knowledge … of the pharmaceutical and clinical development processes and their relationship to the clinical supplies delivery processes; aware of clinical supply GMP requirements and standards. Lean Sigma training/experience Project Management training/experience Experience demonstrating organizational and planning skills coupled with strong written and oral communication skills Demonstrated capability more »
safety guidelines and protocols. Continuous Improvement: Driving factory process improvements through techniques like root cause analysis and downtime analysis. Contributing to plant housekeeping and GMP audits and managing logistics team standard tasks. Measures of Success: Clear logistics strategy and plans. Adherence to logistics budget. Decrease in logistic complaints. On-time more »