Northwich, Cheshire, North West, United Kingdom Hybrid / WFH Options
Dechra
re particularly keen to hear from those who have/are: Extensive Pharmaceutical Industry with hands on experience in development/quality in a GxP environment. Proven track record of implementing phase appropriate quality strategies Direct experience proving quality oversight of CDMOs Excellent working knowledge of FDA and EU GMPs more »
Loughborough, Leicestershire, East Midlands, United Kingdom Hybrid / WFH Options
Almac Group (Uk) Ltd
be beneficial to your application, but is not essential: Bachelors degree (or equivalent) in a scientific or technical discipline Worked within a pharmaceutical/GxP environment in a Quality related role Familiarity with the production of solid dose oral products Management of electronic & physical documentation systems Reward For the successful more »
PMDA and other global regulatory agencies. Who We Are Zigzag Associates partners with companies across the entire drug discovery and development process to improve GxP Quality against global regulatory standards. We are a global, certified woman owned company who put people first and forge lasting relationships to bring deep impact more »
Worthing, England, United Kingdom Hybrid / WFH Options
Hobson Prior
in this location. Key Responsibilities: For this role, you will assist with compliance on all GMP/GDP and GCP regulations guaranteeing adherence to GxP and data integrity legislation. Serve as the System Owner/Administrator role for GxP IT systems that reside within QA. The ideal candidate will carry … data integrity documentation periodically and as needed. Offer aid for any other quality systems which involves Non-Conformances, CAPA, QTAs, as applicable connected to GxP IT systems. Collaborate with IT associates assuring suitable oversight of IT systems. Mediate with IT division associates linked to GxP impact and GxP compliance of … of pertinent change controls. Any other assigned duties. Requirements: Experience with TrackWise, LIMS and Documentum and/or any other QMS systems. Acquaintance global GxP, e.g., FDA CFRs, EU, 'Third countries' other than the UK. Familiarity within a pharmaceutical manufacturing, testing or quality assurance setting in a similar position. Prior more »
Greater London, England, United Kingdom Hybrid / WFH Options
Cognizant
teams to service the client) Good understanding of the Life Sciences or Consumer Goods industry Appreciation of the requirements of operating in regulated environments (GxP, SOX) Excellent communication skills Results driven Building relationships and strengthening partnerships by focusing on exceptional client experience Concepts of financial, marketing and business strategy Business more »
Slough, England, United Kingdom Hybrid / WFH Options
Parkside Recruitment
audits and contract auditors in line with the global audit plan, business model and applicable procedures · Plan, supervise, conduct, and support internal and external GxP audits · Follow-up on the development, implementation and completion of corrective and preventive actions with internal and external auditees · Maintain a tracking tool for audits … Quality System · Ensure continuous improvement and enhancement of the Quality System by supporting global metrics generation and ‘lessons learned from audit/inspection’ · Cover GxP related Functional Areas, specifically thus related to GCP, GVP, GMP and CSV. · Collaborate with the respective Functional Area Heads/representatives · Collaborate with the respective … training procedures in collaboration with other business companies and provide training in the area of expertise as assigned. 3. Inspections · Support the preparation for GxP inspections · Support the responses to Regulatory Authorities · Supervise and provide input to the corrective and preventive actions · Follow-up on the development, implementation and completion more »
Manchester Area, United Kingdom Hybrid / WFH Options
Factorytalk
platform for Pharmaceutical and Biotech customers. This is groundbreaking work, reinventing the MES concept. So, as well as knowledge and experience of MES and GxP IT projects, you absolutely must be open to working in new ways with a flexible and creative mindset in tight collaborative teams with colleagues and … customers. Factorytalk has unique experience and know-how in creating, building, and validating GxP Apps using this modern digitalization tool. You will receive extensive training on Tulip, attain certification, and additional training on Factorytalk’s specialist App design, building, and validation methods to deliver Tulip solutions for GxP use. This more »
as well as other core applications interacting with SAP as per core model Configure SAP to support the business solutions including reporting. Delivers updated GxP validation materials. Provides impact analysis on solution(s) and GxP validation materials. Education/Certifications: Bachelor’s Degree in relevant discipline SAP Certification Preferred on more »
City of London, London, United Kingdom Hybrid / WFH Options
Connect With Ltd
We need someone who has experience working in a Pharma/life science environment who has good knowledge of working in a GMP/GxP environment. This is a strategic role and requires someone who has previous regional experience with some auditing experience. The role is based from home and … for leading the output from a team of QSHE people based in the region. Key responsibilities and activities Successful client and regulatory audits of GxP activities across the EMEA sites. Timely reporting and investigation of quality and safety related incidents and audits. Added value to the business through implementing efficient … working on other Global Pharmaceutical accounts. The group is responsible for conduct of audits, training, and quality/safety investigations, all of which ensure GxP and SHE regulations are satisfied. This position is home based, however travel is expected within EMEA to visit the relevant client sites. Essential Solid grounding more »
Milton Keynes, Buckinghamshire, United Kingdom Hybrid / WFH Options
S3 Science
in alignment with business objectives.Delivery of medium and large site Capital Projects within budget and timelineManagement of project execution resources and vendorsDeliver projects with GxP and Cybersecurity complianceOversee the coordination and management of project execution resources, including internal teams and external vendorsMaintain continuous engagement with all project stakeholders through regular … updates and strategic meetings to ensure alignment and address concernsJob Requirements:Experience in project management within the pharmaceutical or related industry, particularly with GxP complianceProven capability in managing both IT and OT domainsAbility to understand complex applications and OT asset landscapeIn-depth knowledge of Data Integrity, BMS, EMS, and SCADA more »
with established architecture standards, contributing to and evolving them to incorporate new technologies and patterns as neededEnsure compliance with relevant policies and procedures (including GxP validation where required)Provide input to, reviewing and approving key technical documents (e.g. design spec, validation plan)Stay updated with the latest advancements in Knowledge …/Experience:If you have the following characteristics, it would be a plus:Understanding of pharmaceutical industry data and domain knowledge within CMC.Knowledge of GxP compliance requirements and experience implementing them in data engineering projectsPlease take a copy of the Job Description, as this will not be available post closure more »
Stevenage, Hertfordshire, United Kingdom Hybrid / WFH Options
GlaxoSmithKline
with established architecture standards, contributing to and evolving them to incorporate new technologies and patterns as neededEnsure compliance with relevant policies and procedures (including GxP validation where required)Provide input to, reviewing and approving key technical documents (e.g. design spec, validation plan)Stay updated with the latest advancements in Knowledge …/Experience:If you have the following characteristics, it would be a plus:Understanding of pharmaceutical industry data and domain knowledge within CMC.Knowledge of GxP compliance requirements and experience implementing them in data engineering projectsPlease take a copy of the Job Description, as this will not be available post closure more »
Brentford, Middlesex, United Kingdom Hybrid / WFH Options
GlaxoSmithKline
with established architecture standards, contributing to and evolving them to incorporate new technologies and patterns as neededEnsure compliance with relevant policies and procedures (including GxP validation where required)Provide input to, reviewing and approving key technical documents (e.g. design spec, validation plan)Stay updated with the latest advancements in Knowledge …/Experience:If you have the following characteristics, it would be a plus:Understanding of pharmaceutical industry data and domain knowledge within CMC.Knowledge of GxP compliance requirements and experience implementing them in data engineering projectsPlease take a copy of the Job Description, as this will not be available post closure more »