the wider Quality group at Alba Bioscience, part of AliveDx, and its primary role is to ensure that all aspects of GoodManufacturingPractice (GMP) and Good Documentation Practice (GDP) compliance are met through effective control of the Quality Management System (QMS). The role is a full-time temporary … by the business . Participate in an 'in-house' programme of continuous training and assessment. Conduct all duties in compliance with GoodManufacturingPractice (GMP), Good Documentation Practice (GDP) and appropriate regulatory requirements including statutory Health & Safety legislation and internal practice. Perform any other duties as reasonably requested from the more »
satisfy the requirements of external agencies. Responsible for timely and accurate reporting of internal Refresco KPIs to the management team. Be responsible for ensuring GMP and Hygiene standards are communicated to the operational teams and processes are in place to effectively monitor and manage them. Partake in site visits and more »
at a high level. What are we looking for? Essential Degree Qualified in an area related to an Engineering discipline. Experience gained within a GMP environment (or closely related regulatory environment) from an equipment, facilities, and engineering perspective. Demonstrated working knowledge of BMS, EMS & HVAC systems. Strong interpersonal and communication more »
site and related functions in maintaining compliance with GxP regulations and applicable quality guidelines, including, but not limited to UK/EU/US GMP/GDP, ICH and other region specific guidance. The individual will have support key quality system elements and compliance improvements, working closely with relevant stakeholders more »
time. Main responsibilities: Use a range of analytical chemistry techniques- predominantly HPLC Ensuring all analysis and documentation are conducted and recorded in compliance with GMP standards Perform stability study programme activities, storage of in process, and final products samples and retention sample management Working to set protocols within a busy more »
maintained and up to date. Education and experience : *Degree in chemistry, analytical chemistry or equivalent *Previous experience of HPLC, GC analysis with pharmaceutical/GMP regulated environment *Previous experience in analytical method transfer, cleaning validation *your previous experience could be QC analyst, stability analyst, development analyst, principal analyst and raw more »
in Chemistry/Biochemistry/other related science or equivalent experience in a similar setup. - Competent analytical skills, attention to detail, and understanding of GMP requirements. - Ability to work independently and in a team, with strong computer literacy and communication skills. - 1 year of lab based experience is necessary. Are more »
of GCP requirements as applied to biologics and related industry/regulatory guidelines governing clinical trials in the EU & USA.Basic understanding of GLP and GMP requirements for biologicsBasic Knowledge of GLP and cGMP and related industry/regulatory guidelines governing the manufacture of biologics in the UK, EU & US.Ability to more »
+ 8 Bank Holiday Cycle to Work Scheme Skills and Qualifications Required for Analyst BSc or higher in Chemistry or related field Experience within GMP environment Physical characterisation including; particle sizing (image and laser diffraction), specific surface area, XRD, thermal analysis, water content Chemical ID analysis including; UV-vis, FTIR more »
+ 8 Bank Holiday Cycle to Work Scheme Skills and Qualifications Required for Analyst BSc or higher in Chemistry or related field Experience within GMP environment Physical characterisation including; particle sizing (image and laser diffraction), specific surface area, XRD, thermal analysis, water content Chemical ID analysis including; UV-vis, FTIR more »
will conduct, coordinate and support quality aspects of the Company business operation, ensuring quality compliance throughout the business with focus on WDA, MIA and GMP and GDP activities. Key Responsibilities: To ensure that a quality management system is implemented and maintained and appropriate to the activities at the Company inclusive … EU Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C343/01) and EudraLex – Volume 4 – GoodManufacturingPractice (GMP) guidelines. Providing compliance support and spreading the quality culture throughout the company. Maintain processes (GMP documentation lifecycle, Change Control, Deviation, CAPA, self-inspections, Complaints, GMP … the role of the enforcement group, the Inspection Action (IAG) and resulting actions that can be taken due to non-compliance. Good understanding of GMP/GDP. Excellent attention to detail. Effective time management. Self-motivated & highly target driven. more »
the management and improvement of quality systems processes to ensure both EU and US regulatory compliance to relevant company standards and GoodManufacturingPractice (GMP). • Implement and monitor established policies and procedures to ensure compliance with necessary regulatory bodies in the areas of: Corrective and Preventive Action (CAPA), Complaint … Work in accordance with Company Quality Standards, procedures and processes and comply with the requirements of Good Documentation Practice (GDP) and GoodManufacturingPractice (GMP). • Adhere to the standards of behaviours, policies and procedures as laid out in the employee handbook. • All other essential duties as directed more »
Job summary This position presents an exciting opportunity for an experienced radiochemist or radiopharmacist proficient in PET radiopharmaceutical production to GMP standards. As the Production Manager, you will lead our team of radiochemists at the Positron Emitting Radiopharmaceutical Laboratory (PERL), located within St Thomas Hospital. The ideal candidate must possess … expert knowledge in relevant regulatory governance areas, particularly GoodManufacturingPractice (GMP), as well as Health and Safety, Environmental Safety, and Radiation Protection Regulations (IRR2017 and IR(ME)R). This expertise will ensure adherence to these regulations within the PERL facility. Main duties of the job The role entails … managing radiochemists within PERL to ensure timely, safe, and efficient completion of production duties. Emphasis will be placed on compliance with GMP regulations, development of new procedures and radio tracers, and streamlining processes while maintaining safety standards. This includes supporting the installation and validation of new production equipment. The successful more »
Pontefract, West Yorkshire, Yorkshire, United Kingdom
Refresco UK
focus: Actively participate in the implementation of site quality improvement projects, where necessary providing support to train operation teams and monitor project effectiveness. Complete GMP and Hygiene audits to required schedules. Assist in the investigation of consumer complaints and non-confirming items determining root cause and corrective action necessary to more »
Material & Production Planning master data Prior knowledge of manufacturing, production planning & forecasting Have previous experience in a support environment Experience in companies manufacturing to GMP Standards Knowledge of SQL Experience in analytics/dashboarding 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 »
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 »
a cGMP environment Experience of supplier audits and/or vendor assurance would be beneficial Excellent organisational and time management skills Good knowledge of GMP and ISO regulations Awareness of regulatory requirements 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 »
team members on best practices and ensure compliance with regulatory standards. Conduct gap analysis, review change controls, and develop revalidation strategies as needed. Ensure GMP, Data Integrity, and GDP compliance, including timely training. Key Competencies: Proven track record in delivering regulatory-compliant validation strategies. Strong understanding of GxP compliance requirements. more »
as part of the remuneration. Experience: Experienced project engineer or project manager in a pharmaceutical setting A strong understanding and hands on experience of GMP Engineering or validation experience is essential Exposure to the full validation lifecycle and the ability to walk through the full CQV phase Hands on experience 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 »
track record in this regard. Exhibit adept conflict resolution skills, further enhancing your capacity to lead effectively. Have experience working within environments governed by GMP regulations (at least 4 years). How to Apply: Don't miss out on this amazing opportunity! Submit your application. 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 »
Liverpool University Hospitals NHS Foundation Trust
correctly. Ensure that the aseptic process is carried out in compliance with current Standard Operating Procedures following the principles of the GoodManufacturingPractice (GMP). About us Liverpool University Hospitals NHS Foundation Trust was created on 1 October 2019 following the merger of two adult acute Trusts, Aintree University … correctly. Ensure that the aseptic process is carried out in compliance with current Standard Operating Procedures following the principles of the GoodManufacturingPractice (GMP). See Job Description for further information. Person Specification Experience Desirable Experience working in Healthcare Environment Experience of stock rotation Experience of working in stores more »