and Quality Control Laboratory systems and software used to support the manufacture, packaging, testing, storage and distribution of marketed drug products comply with current GMP and company expectations. Provide input to the review and writing of any associated quality policies, systems and procedures as required and prepare and update SOPs … applications providing independence of access for administrator activities Ensure Qualification and Validation of equipment, processes, systems is/are performed in line with procedures, GMP and GAMP guidelines for process, equipment and electronic systems, as and when required. Ensure the maintenance of procedures supporting Qualification and Validation and review and … of data integrity and application to system management Good understanding of Quality Control Systems and analytical software and electronic Quality Systems Good understanding of GMP Guidelines and Regulations Knowledge of the qualification and validation requirements for equipment and electronic systems Excellent verbal and written communication skills. Apply: It is essential More ❯
dependant on performance), company pension, onsite parking Major Duties and Responsibilities • Reviewing Batch records and creating the associated checklists to support batch certification • Archiving GMP critical documents in line with company policy • Ensuring current versions of controlled documents are available to site personnel • Assist in Audits • Proactively identifying risks within … release testing in a timely manner The Person • Minimum degree in pharmacy, biomedical sciences, or any other scientific degree. • 2 years' experience in a GMP/GLP role. • Experience in CAPA, OOs, OOt, deviations, change controls etc in a GMP setting • Willingness to learn. • Strong administrative s... More ❯
site (supporting documentation and validation reviews), working with equipment manufacturers where necessary. Frequent interaction with Quality and Safety Practitioners and Regulatory bodies (via regulatory GMP audits and product market-specific audits). This may include preparing and presenting at Technical Quality Audits. Delivering (and promoting) a culture of improving the … of the plant). Improvement of procedures relevant to the OSD Engineering Department. About You: Knowledge of and experience of working within highly regulated (GMP) environments A good standard of numeracy and literacy is essential. You will be a willing learner and a good communicator who takes personal accountability, ownership 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 ❯
currently working with a Pharmaceutical Company in the North West to recruit a QA Officer to join a small team responsible for all aspects GMP compliance within their Sterile manufacturing facility on a 12 month fixed term contract. This QA Officer position is a brilliant opportunity for candidates with prior … GMP experience to further their career within QA with a company who can provide strong progression opportunities or for people with a background in GMP laboratories who are keen to transition to QA. Key Responsibilities Respond to and action quality enquiries and quality management activities including deviations, change controls, risk … assessments, complaints etc. Support internal and external GDP/GMP audits Author, review and archive quality documentation including SOPs, PQRs, supplier agreements Ensure GMP compliance at all timesKey Requirements Prior GMP experience within the pharmaceutical/medical device industries is essential Prior experience working with Pharmaceutical Quality Management Systems is More ❯
projects in accordance with the company project roadmap throughout the project lifecycle ensuring governance to current engineering standards and compliance with CDM regulations. Strict GMP compliance to be adhered throughout the lifecycle of the project. Coordination with the Principal Contractor and all other project team members to ensure completion to … budget and provide accurate monthly reports Attendance at daily update meetings Ensure compliance with all HSE & CDM requirements Ensuring compliance of project delivery with GMP requirements and company UKSL SOP’s Develop and updated project schedule defined appropriately according to project stage-gate Identify, record and monitor project risks, seeking … level Project Engineer/Project Manager with experience in managing cross functional teams, delivering complex Manufacturing Facility and processing projects, in a highly automated GMP production environment Demonstrated capacity to effectively manage and execute projects from initiation to completion Full project lifecycle experience from end to end design through to More ❯
projects in accordance with the company project roadmap throughout the project lifecycle ensuring governance to current engineering standards and compliance with CDM regulations. Strict GMP compliance to be adhered throughout the lifecycle of the project. Coordination with the Principal Contractor and all other project team members to ensure completion to … budget and provide accurate monthly reports Attendance at daily update meetings Ensure compliance with all HSE & CDM requirements Ensuring compliance of project delivery with GMP requirements and company UKSL SOP’s Develop and updated project schedule defined appropriately according to project stage-gate Identify, record and monitor project risks, seeking … level Project Engineer/Project Manager with experience in managing cross functional teams, delivering complex Manufacturing Facility and processing projects, in a highly automated GMP production environment Demonstrated capacity to effectively manage and execute projects from initiation to completion Full project lifecycle experience from end to end design through to More ❯
projects in accordance with the company project roadmap throughout the project lifecycle ensuring governance to current engineering standards and compliance with CDM regulations. Strict GMP compliance to be adhered throughout the lifecycle of the project. Coordination with the Principal Contractor and all other project team members to ensure completion to … budget and provide accurate monthly reports Attendance at daily update meetings Ensure compliance with all HSE & CDM requirements Ensuring compliance of project delivery with GMP requirements and company UKSL SOP’s Develop and updated project schedule defined appropriately according to project stage-gate Identify, record and monitor project risks, seeking … level Project Engineer/Project Manager with experience in managing cross functional teams, delivering complex Manufacturing Facility and processing projects, in a highly automated GMP production environment Demonstrated capacity to effectively manage and execute projects from initiation to completion Full project lifecycle experience from end to end design through to More ❯
To complete customer line forms, questionnaires and specification requests. To set up and maintain data in the companys ERP system(s). To undertake GMP audits according to agreed audit schedule, distribute the results and ensure the closure of actions raised. To lead and/or participate in root cause … methodical, with excellent administrative and strong communication skills. Good relationship building skills with both internal and external stakeholders. An understanding of the principles of GMP and Global Food Safety Initiatives. Personal Skills An excellent multi-tasker, able to manage multiple projects simultaneously and who thrives in a fast paced role More ❯
/office arrangement as the business requires. The role of the Senior Technical Editor is to manage the creation of new documents and revise GMP documents for complex technical changes. Key responsibilities: Independently manage the creation of new documents and revise GMP documents for complex technical changes according to documented … Tasks and CAPAs Creation and coordination of Change controls and completion of change assessments in Trackwise in conjunction with internal Lonza donors Maintenance of GMP document templates and document style and format standards Advise on document style and content, use of DMS, documentation procedures and documentation best practice and provide More ❯
/office arrangement as the business requires. The role of the Senior Technical Editor is to manage the creation of new documents and revise GMP documents for complex technical changes. Key responsibilities: Independently manage the creation of new documents and revise GMP documents for complex technical changes according to documented … Tasks and CAPAs Creation and coordination of Change controls and completion of change assessments in Trackwise in conjunction with internal Lonza donors Maintenance of GMP document templates and document style and format standards Advise on document style and content, use of DMS, documentation procedures and documentation best practice and provide More ❯
with a Pharmaceutical Company in North Wales to recruit a QA Officer to join a small team responsible for all aspects of GDP and GMP compliance. This QA Officer position is a brilliant opportunity for candidates with 1+ years GDP/GMP experience to further their career within QA with … Respond to and action quality enquiries and quality management activities including deviations, change controls, risk assessments, complaints etc. Support internal and external GDP/GMP audits Author, review and archive quality documentation including SOPs, PQRs, supplier agreements Ensure GMP/GDP compliance at all timesKey Requirements Prior GDP/GMPMore ❯
an exciting opportunity to work in a fast-paced environment, ensuring the quality and compliance of laboratory work in line with ISO 17025 and GMP standards. Key Responsibilities : Ensure compliance with company policies and procedures, including Health and Safety, ISO 17025, and GMP. Review, write, and amend documentation such as … SOPs. Manage controlled documentation and maintain its circulation and availability. Audit GMP data, including reviewing raw data prior to releasing GMP CoA or CoP. Coordinate quality issues, investigations, and CAPA. Assist with OOS, NC, NTF, CMP, RA, and CAPA investigations. Participate in the change control process to ensure changes maintain … GMP compliance. Track, trend, and gather data for meetings as per procedures. Conduct staff training on quality matters when required. Liaise with customers or regulatory representatives. Host and manage external audits by customers or regulatory bodies. Respond to external audit... More ❯
