1 to 25 of 133 GMP Jobs

Ensures that there are robust processes in place for the review and release product for GLP and GCP studies. Ensures appropriate quality oversight of GMP activities performed by the Product Development teams at Dechra or CDMOs and contract laboratories. This may include review and approval of protocols, reports, methods, master more »

this role you must have the right to work 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 more »

and contribute to maintaining and developing QMS related to IT. Key Responsibilities: Ensure ongoing compliance of GxP IT systems and processes. Support adherence to GMP/GDP and GCP regulations, including data integrity legislation. Act as System Owner/Administrator for GxP IT systems within QA. Lead Computer System Validation more »

the management and improvement of quality systems processes to ensure both EU and US regulatory compliance to relevant company standards and Good Manufacturing Practice (GMP). The successful applicant will: Implement and monitor established policies and procedures to ensure compliance with necessary regulatory bodies in the areas of: Corrective and … Work in accordance with Company Quality Standards, procedures and processes and comply with the requirements of Good Documentation Practice (GDP) and Good Manufacturing Practice (GMP). Deputise for Senior Quality Systems Engineer when required, to ensure progression of departmental commitments. We are looking for someone who has: Minimum A level … Directive MDD 93/42/EEC Knowledge of FDA QSR Part 820 Computer literate to include MS Word, Excel and MRP Knowledge of GMP and audits Ability to work with minimal supervision and use initiative. Good interpersonal skills and the ability to communicate well in English both written and more »

well established Quality team, focusing on the supply chain. We are seeking a detail-oriented and experienced QA officer with a background in pharmaceuticals (GMP) and an understanding of Good Distribution Practice (GDP). The ideal candidate will ensure compliance with regulatory standards, optimize supply chain processes, and uphold company more »

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 Global and Regional Quality Leads and functions · Ensure the establishment more »

GCLP, CLIA, CAP, ISO15189 laboratory requirements Experience in CLSI, NYDOH and other industry standards for assay validation; Understanding of IVD regulations including QSR regulations, GMP manufacturing, ISO13485, and FDA and EU medical device regulations. Preferred Qualifications & Skills: Please note the following skills are not necessary, just preferred, if you do more »

stakeholders. Strategic thinking and problem-solving abilities, with a proactive approach to regulatory challenges. Familiarity with quality management systems and regulatory compliance frameworks (e.g., GMP, GDP, GCP). Ability to thrive in a fast-paced, dynamic environment and effectively prioritize competing demands. more »

required certifications): Scientific Degree or an equivalent in Chemistry, Biology, Pharmacy or Pharmaceutical Engineering; Min. 5 years of experience in quality operations in the GMP environment; Other languages are an asset; Knowledge and understanding of regulatory requirements; Good knowledge in office tools (e.g. Word, Excel, SAP). Additional Preferences: Working more »

manager in accordance with company requirements. Shift work and out of hours work as required. Experience Working within a QC laboratory environment, working to GMP within a recognised quality system. Minimum of 2 Years experience of working in a Supervisor/Senior role. Ability to prioritise, organise and schedule work more »

Team Leader, you will be responsible for up-keep and compliance of the QMS, overseeing internal company processes to ensure the business is always GMP and GDP complaint and lead a team of 3 QA Officers working directly with the Head Of Quality. Responsibilities for the Quality Assurance Team Leader more »

have requirements: 2-5 years’ experience working with MES/EBR or similar systems in the life sciences industries. Experience deploying MES in a GMP environment, configuring Recipes, MBR’s, Materials, BOMs, Order Management, Equipment management, Batch Review/Approval and other typical components. A background in one or more more »

Undertake other duties in relation to the position as the Company requires, including working additional hours as requested by the Systems Delivery Manager Ensure GMP is adhered to in all areas of work. Understand Company’s Health & Safety Policy and follow all company HSE procedures.Report all accidents or any unsafe more »

manufacturing operations. Are you a QA Manager that has experience Performing QA Duties to ensure manufacturing, testing and clinical trial activities that comply with GMP, GCP and other regulatory guidelines Document Control systems Change Controls CAPA - Corrective and Preventative actions Deviations & OOS reporting Compliant and recall handling Performing internal Audits more »

are looking for experienced pharma QA Auditors with strong written and verbal English skills, as this role involves a lot of report writing. Responsibilities: GMP/GxP Audits of vendors and contract manufacturers, assessing compliance with regulatory requirements, to provide quality oversight and guidance to identify quality risks, assess severity more »

in one of the following fields of study: Biology, Biotechnology, Biochemistry or similar. An aptitude for Critical thinking and problem solving. Experience in a GMP Regulated CDMO would be beneficial. Experience working within Analytical Development environment. Experience of reagent preparations and material handling. Knowledge of equipment and instrument calibration, qualification more »

be considered, to be clear we are looking for someone who has commercial lab experience working to QMS like UKAS 17025 or GLP/GMP/BRC) or GC/MS experience Strong interpersonal, organisation skills Able to work towards deadlines Good IT skills Important Information: We endeavour to process more »

Knowledge of developing injectable dosage forms for preclinical & clinical use, this will include formulation development and product characterisation Appreciation of the regulatory environment, ideally GMP/GLP You will be able to coordinate multiple projects simultaneously You will be an effective team player and have strong interpersonal skills to enable more »

promoted internally. 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 more »

degree level or above in life sciences, chemistry or a related file with experience of working in a regulated laboratory environment (e.g. GLP or GMP) • Experience in using and troubleshooting ELISA analytical systems as well as the ability to develop and validate analytical methods using ELISA. • The ability to document more »

QA Specialist Moreton, GB (Hybrid) 12 Month Contract – Likely Extensions/permanency £20 per hour Function PDQ Good Manufacturing Practice (GMP … serves as the Quality Assurance Unit overseeing manufacture, testing and distribution of clinical supplies (investigational products) to assure quality and compliance with Good Manufacturing Practices (GMP) and other applicable regulations and internal procedures. Key responsibilities include drug substance and drug product batch disposition (release/reject decision), product certification and … release by the UK/EU Qualified Person, and audit of internal GMP systems/processes and suppliers/third party contractors, as well as assist stakeholders with regulatory advice and preparation for and management of regulatory agency inspections. Primary Responsibility: Review and label vendor specifications in accordance with relevant more »

monitoring good manufacturing practices, applying HACCP principles and preventing reoccurrence of non-conformance against these standards. To audit compliance against Quality Management Systems and GMP, raising all non-conformances against relevant standards with objective evidence enabling the operational teams to take the appropriate and necessary corrective action, to follow up more »

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 more »

Technology (OT) and aspiring to make a meaningful impact? You are a customer focused individual with aspiration to deliver high quality support in a GMP Lab environment. We Make Medicines! Behind every product sold by Roche is Pharma Global Technical Operations (PT). Starting with Phase I of the development more »

and vision systems integrated within packaging equipment including interfaces with enterprise systems. Responsible for providing cGMP compliant control systems as per GAMP5 and EU GMP Annex 11. Key Experience Essential - Practical experience working within manufacturing and packaging environments Experience of the automation project lifecycle including design, configuration, implementation, testing, commissioning more »