1 to 25 of 104 GMP Jobs

skills. - Experience dealing directly with customers on quality matters. - Excellent communication and stakeholder management skills. - The ability to work independently while managing multiple priorities. - GMP experience (desirable). - Degree or equivalent in a science, engineering or manufacturing discipline (desirable). This is an excellent opportunity for an experienced Quality Assurance ...

engaging and dealing project stake holders and work cross functionally. (E) An Understanding of CSV requirements in accordance with FDA 21CFR Part11/EU GMP Annex11 regulations and ISPE GAMP5 Guidelines (E). Validation project management (P) Familiarity of SaaS/Cloud based systems validation utilising modern CSA approach. ...

Understanding of relationship between Complaint Handling, CAPA, Nonconformance and Risk Management processes Knowledge of ISO 13485and 14971, FDA21CFR Part 803, 820, 822, 806, EU GMP Annex 11 Proven ability to work both independently and in teams in a dynamic, fast-moving environment Good understanding of SaaS and GxP principles Ability ...

KPIs and customer feedback, championing continuous improvement, automation and a customer focused support culture.We are looking for:Proven experience supporting enterprise IT infrastructure and GMP-regulated computerised systems within a regulated environment.A degree in a relevant field or HNC/HND would be advantageous.Strong technical knowledge of operating systems, networking ...

feedback, championing continuous improvement, automation and a customer focused support culture. Profile description: We are looking for: Proven experience supporting enterprise IT infrastructure and GMP-regulated computerised systems within a regulated environment. A degree in a relevant field or HNC/HND would be advantageous. Strong technical knowledge of operating ...

relationship between Complaint Handling, CAPA, Nonconformance and Risk Management processesKnowledge of ISO 13485 and 14971, FDA 21CFR Part 803, 820, 822, 806, EU GMP Annex 11Proven ability to work both independently and in teams in a dynamic, fast-moving environmentGood understanding of SaaS and GxP principlesAbility to quickly understand business ...

data and presenting insights Regulatory & Compliance Knowledge (Critical in LIMS) Understanding of: GxP (Good Practice standards) FDA 21 CFR Part 11 ISO 17025/GMP Knowledge of: Electronic signatures Audit trails Data validation processes On-premise and cloud-hosted LIMS Security concepts Analytical & Domain Skills Laboratory domain knowledge: Understanding ...

across global pharma accounts, CDMOs, and CGT innovators. Build, manage, and expand multi-stakeholder relationships across Manufacturing, Clinical R&D, production, QA/QC, GMP IT, and procurement functions. Develop and execute account-based strategies for Tier 1–3 Pharma, MedTech, CDMOs and CGT manufacturers. Engage and build relationships with ...

logistics frameworks, and aligning programme milestones with cost, procurement and delivery objectives.Support the development and management of project budgets from early design through GMP, and reviewing contractor cost submissions to ensure accuracy, value and alignment with project objectives.Lead procurement and contractor engagement activities by developing delivery and sourcing strategies, managing ...

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 ...

Oriented Programming Git version control Basic electrical, mechanical and pneumatic knowledge Robotics Machine Vision SCADA/MES systems Pharmaceutical or regulated manufacturing environments GAMP, GMP, 21 CFR Part 11 or EU Annex 11 Industrial communication protocols including EtherCAT, Profinet, CAN, Ethernet/IP and Serial communications .NET ...

Experience with industrial automation systems and OT architecture, including integration with IT systems Familiarity with regulated environments and standards such as GxP (including GMP and GAMP5) and IEC 61508/61511 Understanding of cyber security risk assessments, controls, and system documentation Experience in system lifecycle management, including validation, change control ...

Experience working within pharmaceutical, medical device or regulated manufacturing environments would be advantageous. Knowledge of GAMP, 21 CFR Part 11, EU Annex 11 or GMP would be beneficial. Strong communication skills with the ability to work effectively within a team. A willingness to travel occasionally (typically less than ...

Coordinate & take part in internal and external design reviews, DQ, HAZOP and site meetings where required. Author, review and be responsible for project lifecycle GMP/validation documentation – technical writing is a core skill. Contract management – clearly understand the commercial aspects of each assigned project and liaise with contract managers ...

analysis, reports, and insights to support business performance reviews Supporting supplier and grower visits to assess quality performance and identify opportunities for improvement Conducting GMP and Food Safety audits and supporting wider site compliance activities Coordinating and managing the sample approval process Identifying opportunities for innovation, continuous improvement, and best ...

Role Accountabilities • Deliver a risk-based programme of internal and supplier audits to assess compliance with food safety, quality, legality and customer standards • Evaluate GMP, hygiene, HACCP, allergen controls and traceability during audits to ensure sites meet required standards • Plan, conduct and report audits independently across multiple categories, processes ...

. Participate on cross-functional continuous improvement teams; occasional travel to other sites may be required. Follow all safety protocols and Good Manufacturing Practices (GMP) and adhere to company policies and recognized best practices. Execute a robust preventive maintenance program and maintain accurate maintenance records. Install, maintain, and calibrate industrial ...

quality systems are adhered to, support investigations, conduct audits and help drive continuous improvement initiatives across the site. Key Responsibilities Conduct internal audits covering GMP, hygiene, traceability, product quality, documentation and manufacturing processes, ensuring corrective actions are completed effectively. Investigate quality, food safety and compliance issues, including customer complaints ...

62443Experience with industrial automation systems and OT architecture, including integration with IT systemsFamiliarity with regulated environments and standards such as GxP (including GMP and GAMP5) and IEC 61508/61511Understanding of cyber security risk assessments, controls, and system documentationExperience in system lifecycle management, including validation, change control, and documentation practicesKnowledge ...

conformance, customer complaint investigations, glass & plastic audits, and fabrication audits. - Supporting the training of staff and verification against CCPs, policies and procedures. - Conducting internal GMP audits across departments and conducting hygiene verifications. - Assisting with external audits. The role will be a mix of factory and office-based work to meet ...

coach, develop and inspire technical teams. Desirable Experience within medical devices, healthcare technology or other safety-critical industries. Knowledge of IEC 62304, ISO 13485, GMP and FDA-regulated environments. Experience with cloud platforms such as Azure, AWS or GCP. Understanding of cybersecurity for connected devices and IoT systems. Exposure ...

electrical schematics and technical drawings Good understanding of mechanical systems (gearboxes, bearings, conveyors, pneumatics) Knowledge of food safety standards such as BRC, HACCP, or GMP Strong problem-solving skills and ability to work independently Benefits Opportunity to work in a modern food manufacturing facility Ongoing training and development Pension scheme ...

ProfileThe ideal candidate will have experience working as an engineer within a production/manufacturing environment, but this is not essential.Experience working in a GMP regulated facility or similar (BRC, ISO 9001, BETA NOPS) is desirable but not essential.Candidates must also have a good level of IT knowledge (Word, Excel ...

conjunction with Production Management To assist with preparation of the site for audits from both internal and external expectation To manage the site GMP audit system and be a member of the site internal auditing team To assist with the recording of all necessary KPI information weekly In the absence ...

Calibration Management System if applicable, as directed by the Site Instrumentation Manager. Maintain all documentation in an organised and controlled manner in compliance with GMP and FDA Work with operation teams as required facilitating calibration activities Carry out calibrations in a safe and timely manner Carry out corrective/reactive ...