a Qualified Person to join our team at Harlow, UK. The successful person will perform the quality assurance activities and quality oversight of the GMP functions performed within Pharma R&D. As a Qualified Person, is personally accountable to conform to the legal regulatory requirements as stated in Clinical trials more »
and improvement of the Quality Management System (QMS). Assure the compliance of all activities with Good Distribution Practice (GDP) and GoodManufacturingpractice (GMP) requirements. Responding to medical information enquiries from healthcare professionals, community pharmacies, patients, and wholesalers. Ensuring the completion of checks for new products; having the appropriate more »
Chain) Represent the business to external stakeholders as the MSAT technical expert Collaborate with R&D to ensure the early pipeline is compatible with GMPmanufacturing To be a successful candidate for the Senior MSAT Scientist role: Masters or PhD education (Life Sciences, Biochemistry, Biotechnology or similar) Previous experience in … GMP experience Cell Culture | Upstream | Specialist | MSAT | CMC | Cell Therapy | Technical Operations | Scientist| Downstream | Tech Transfer | MS&T | Technical Transfer | Process Development | GMP | goodmanufacturingpracticemore »
analytical team to contribute to the overall group objectives and development of staff. Ensure that own work, and that of the team, complies with GMP, Good Documentation Practice (GDP) and GxP Data Integrity guidance's, and is undertaken in accordance with applicable procedures (e.g., SOP's, Protocols, etc). Requirements … Proven track record of managing a team within a cGMP QC analytical environment. Degree in a relevant scientific discipline or equivalent experience. Understanding of GMP requirements e.g. legislation, guidelines and requirements related to Gene Therapy, QC method qualification and validation, QC processes, equipment and systems, including Computer System e.g. of … EU GMP requirements for Advanced Therapy Medicinal Products, EU/FDA GMP guidelines, EU Annex 1, EU Annex 11 & CFR Part 11 and ICH guidelines Q1-Q10. Apply now If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy more »
Governance Team, you will contribute to the provision, continuous improvement, and delivery of a World Class service to the site, ensuring statutory, regulatory and GMP Compliance requirements are met. Accountabilities: As an Accountable Engineer, you will establish collaborative ways of working to build and manage strong internal customer & supplier relationships. more »
always opportunities to learn and gain exposure. Experience: Previous experience in a QA position within a pharmaceutical, healthcare or food setting Working experience of GMP Operational Quality Assurance experience including batch review/release Exposure to handling complaints processes Lifecycle experience of deviations, CAPAs and change controls Strong stakeholder management … Mark Bux-Ryan for further information quality, assurance, QA, QC, control, analytical, chromatography, HPLC, laboratory, documentation, analyst, officer, specialist, executive, administrator, good, manufacturing, practice, GMP, GLP, audit, SOP, training, complaints, batch, review, release, CAPA, deviation, change, control more »
values, promoting an ethical, positive company culture To maintain consistent and documented compliance with all relevant Safety, Health and Environmental (SHE), GoodManufacturingPractice (GMP), Data Integrity (DI), quality and best practice requirements To work collaboratively with Pharma and Health Tech leadership team to develop a Sustainability Roadmap that supports more »
London, England, United Kingdom Hybrid / WFH Options
i-Pharm Consulting
role will be joining the UK team, as a senior individual contributor and part of a global team. Other essential responsibilities include: Management of GMP and GDP compliance Management of complaints, CAPAs, risk assessments, and validation protocols Review and manage the QMS system Able to manage non-compliance issues and … requirement will be that you are able to travel to West London site and to supplier sites. It is a must that you have GMP and GDP experience. The role will be joining a team which is integral to the business and requires strong communication skills. The team are close more »
is ideal. 2. Proven industry experience in HPLC/LCMS as well as a background of maintenance and troubleshooting skills in a GLP/GMP environment. 3. Experience with other Analytical Instrumentation such as MALDI, Prep LC and SFC is beneficial but not essential. Key Words: Field Service Engineer | HPLC … LCMS | MALDI | Prep LC | SFC | Maintenance | GMP | GLP | Service Schedules | Installation | Validation | Instrumentation | IQOQ | SAP | Troubleshooting | Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for more »
Cheshire, Chester, North West Hybrid / WFH Options
Real Staffing
providing direction and leadership to staff to ensure a quality mindset is embedded in the business Requirements: Expert in GCP with working knowledge of GMP 5 years experience in a QA Manager role within a CRO, Biotech or Pharma company Contract: Hours: 3 days a week - can worked across more »
be accountable for all commercial elements of the Small Molecule and Protein Delivery strategy comprising of M&A, licensing, innovation product promotion and wider GMPmanufacturing strategy to deliver double digit organic and inorganic growth in line with business expectations. Who we're looking for: Degree qualified (ideally MBA) with 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 »
knowledge of material design such as solid state science, material science, structural informatics, data sciences, and work experience from a regulated environment (GLP/GMP). A habit of driving continuous improvement and Lean culture. Cultural awareness. Desirable requirements Scientific leadership skills, the ability to deliver robust scientific contributions to more »
and updating risk assessments and risk mitigation procedures. Train necessary staff in relevant fields related to technical compliance. Implement and deliver site quality and GMP compliance metrics: tracking and investigating consumer complaints, internal and external audit outcomes, and customer compliance. Deliver successful customer and external audits: completion of a gap more »
with regulatory standards and fostering a culture of continuous improvement. Key Responsibilities: Manage all site-related QA operations in accordance with Quality Agreements and GMP guidelines. Serve as the QA representative on the Site Leadership Team. Lead adherence to local or corporate Quality Management Systems (QMS). Collaborate in developing … for site use. Conduct external audits as necessary. Provide strategic input into decisions impacting the Quality Assurance department. Deliver QA-related training and basic GMP training as needed. Act as a subject matter expert on Quality-related processes. Lead or represent QA in related projects, identifying metrics, issues, and mitigation … and develop a team of QA professionals. Support quality-related activities across sites as required. Minimum Qualifications and Experience: Minimum 10 years' experience in GMPmanufacturing, with a focus on QA/Quality roles. Experience in QA support for ATMP manufacture preferred. Demonstrated leadership of small QA teams. Proficient in more »
the company’s procedures relating to your area of work Deliver a right first time quality product Embrace the company initiatives (Right First Time, GMP) Ensure break-downs and requests for engineering assistance are addressed within a timely manner Ensure work is managed in a professional manner and relevant parties more »
are under control Check compliance to Food Safety and Quality Management System procedures (QMS) including control measures for Allergens Conduct GoodManufacturingPractice audits (GMP) audits/Compliance Observation Process (COP) checklist Complaint investigation Check products against factory product specifications to ensure compliance with specifications, legality, and consistency in quality more »
activities. What you'll need to succeed Our client is looking for an individual with strong experience as a Quality Assurance Officer within a GMP Pharmaceutical/Cleanroom environment. Other key desirables include: Quality Management System activities and maintenance. Experience in participating in internal/external audits. Be able to more »
Slough, England, United Kingdom Hybrid / WFH Options
Parkside Recruitment
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 »
Manchester Area, United Kingdom Hybrid / WFH Options
Factorytalk
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 »
with all company policies and procedures. Employee works in accordance with the installed ISO 9001 quality system and, if applicable, works in accordance with GMP-API. Your Profile BSc with previous working experience in a peptide lab is essential, MSc preferred Previous experience in a similar role would be desirable more »
University Hospitals Coventry and Warwickshire NHS Trust
study feasibility assessment and study setup including prescription, worksheet and SOP generation. Ensure pharmacy comply with all aspects of EU and UK legislation, GCP, GMP and GDP pertaining to clinical trials. To follow departmental SOPs for storage, handling, accountability and destruction of Investigation Medicinal Products both within Pharmacy and outside 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 »
in a multi-talented and compliance orientated team. You have · A background in a scientific discipline (MSc is a plus) · Experience working within a GMP environment, preferably in a CDMO · Strong experience of QC environment and organisation · Experience of reagent preparations and material handling Touchlight Benefits Touchlight is a successful more »
on a permanent basis. The Validation Manager will be leading the validation function to be able to execute report activities within the framework of GMP - Annex 11 & 15 in compliance with QMS requirements. In addition, they will be supporting multiple validation projects, liaising with the project departments and the associated more »