profile and past history: 1. Relevant degree in a chemistry related discipline. 2. Proven industry experience in development activities for drug development in a GMP environment. 3. A working knowledge and practical experience with management of an analytical chemistry function/facility in the pharmaceutical industry. Hyper Recruitment Solutions Ltd more »
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 »
be key. You will be energetic, punctual, proactive, and reliable with the ability to lead, guide, and motivate others towards achievement whilst maintaining goodGMP Standards. What you can expect from us: When joining us you can expect a highly competitive rewards package including group pension and other flexible benefits more »
URS, DRR/VRA, IOQ, OCD, C&QR, RTM, and VR. Execution and approval of the corresponding protocols to release the required equipment for GMP production Weekly Validation Report Draft, execution, and approval CSV/CQV validation protocols Qualifications & Requirements: Applicants will have experience of general validation on multiple projects 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 »
Bishop's Stortford, Hertfordshire, South East, United Kingdom Hybrid / WFH Options
HR GO Recruitment - Bishop's Stortford
to detail and flexibility. Strong communication skills. Ability to handle stressful situations and controversial issues. Willingness to learn and develop new skills. Knowledge of GMP, GDPR, LSAS, and ethical trade issues. Key Tasks: Prepare and submit regulatory documentation for market registration. Support root cause identification and solution resolution. Conduct and more »
methodologies, 21 CFR Part 11, and GAMP. Develop detailed specifications, engineering documents, SOPs, and operating standards. Oversee and manage process control automation in a GMP-regulated manufacturing environment. Handle process change control requests according to established SOPs and processes. Lead technical root cause analysis, incident investigations, and troubleshooting for process more »
a BA - circa 5+ years to work independently. Experience with Veeva and other quality systems. Must understand GXP. Order of focus - GCP, GDP/GMP and then GLP. Extensive experience and knowledge in Quality Assurance in Pharma/biotech space to interact with stakeholders. Not a validation specialist but understands 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 »
+ 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 »
The Newcastle upon Tyne Hospitals NHS Foundation Trust
service, we will do our best to make it work for you. Person Specification KNOWLEDGE Essential Up to date knowledge and understanding of GCP,GMP and its application Evidence of preparing worksheets/procedures Knowledge and understanding of the Law and Ethics relating to the dispensing of medicines. Working knowledge 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 »
facilitate change. The ability to present information coherently, accurately and persuasively. PC literate Experience within food manufacturing, advanced Food Hygiene Certificate & good understanding of GMP/hygiene standards Please click ‘Apply Now’ to be considered for this fantastic opportunity and to become part of our Proud Bakkavor family. #LI-HF1 more »
in place to meet legal and statutory requirements. Keep records and provide reports in accordance with good engineering practices to external audit standards. Upholding GMP engineering standards across site, statutory inspections are compliant, and any non-conformances are closed out with root cause analysis to avoid repeat failure. Lead the more »
part of the process. Engage regularly with multi disciplined teams/training and mentoring. Worked within an Automotive/Pharmaceutical/Medical device/GMP environment. Bachelors degree or equivalent in Engineering. DMAIC (desirable). Lean/Six Sigma qualifications. Travel requirements; Travel between local manufacturing sites is required – no more »
for scaling up and down of bioprocess operations. - Understanding of how to develop and optimise processes for the purification of biopharmaceutical products. - Understanding of GMP and QbD considerations in a large scale manufacturing environment. - Understanding and experience with statistical and modelling software and tools. - Understanding of in-process assays such more »
I am currently supporting a CDMO based in Sawston that provide GMPmanufacturing of ATMP's and related products, process development and ancillary services in their search for a Validation Manager. In this role you will be responsible for leading validation, qualification and verification of manufacturing equipment, facilities and lab 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 »
Facilitate flow of information with Quality and Finance departments. Supporting the Supply Chain and Operations to enable that all assets, processes and procedures meet GMP/GDP requirements. Maintain a complete understanding of the flow to ensure an efficient process. Be able to translate forecasts into production schedules, batch allocations more »
