We found 347 job(s) for you:

  • QMS and Compliance Lead

    Salary: £0 Location: SALISBURY

    Focused on curing the worlds deadliest diseases, this pioneering biopharma is now seeking a QMS and Compliance Lead to join their team on a fixed term basis. Acting as QMS and Compliance Lead will see you at the helm of a Cross Disciplined team, delivering compliant Quality Systems and developing an industry leading QMS. Other duties include: • To keep up to date with the requirements of the Medicines Authorities across the EU and rest of world (where relevant) • Provide oversight and direction to development and GCP teams to enable new products to be brought to market. • To provide input and leadership with the Quality Management System (QMS) within the business to drive simple compliant systems. • Assistance with regulatory inspections and client audits. • To promote and uphold the highest standards of professionalism in order to create, maintain and enhance the reputation of the business, amongst its customers and stakeholders both nationally and internationally • To review company Project Files (PSFs, commercial project files etc) to ensure compliance with the current regulatory requirements and company procedures. • To deliver continuous improvement in all areas of the business to enhance the quality, delivery, rate of growth and competitiveness • To liaise and interact positively with appropriate regulatory authorities to ensure company compliance This is a fantastic opportunity and an opportunity to join a team where you can be proud to be producing life-saving products that really make a difference. The company boasts flexible working hours, innovative projects and an incomparably intelligent team to work alongside.

  • Regulatory Affairs Officer

    Salary: £35000 Location: Borehamwood

    Based in Hertfordshire, my client manufactures a wide range of plasma-derived therapeutic products which are distributed to over 40 countries worldwide. They are committed to supporting both healthcare professionals and providing a continuous supply of reliable, high quality, life saving products to patients on a 24/7, 365 day a year basis, and have a vibrant 60-year heritage and is currently embarking on an ambitious programme of investment in research, technology and manufacturing methods to grow the business significantly over the next few years. They are currently recruiting for a number of positions and are interested specfically in receiving applications from qualified regulatory affairs officers with the following skills; + Min of 3 years experience in a Regulatory Affairs function + Solid experience with licencing activities in Middle East countries, South America and Asia. + Knowledge of generation and maintenance of Company Core Safety Information (CCSI) + Experience with the end-to-end procedure for generation of drug labels and maintaining compliant drug labels in the UK and 'rest of world markets' + Experience of dealing directly with Health Authority assessors, in particular the MHRA. + Demonstrated effective communication and collaboration with agents and distributors in 'rest of the world 'countries. + Knowledge of current legislation and guidance related to labelling of medicinal products. + Knowledge or experience of generating eCTD documentation packages, in particular Module 1 Salaries are dependent on experience.

  • Product Manager

    Salary: £50000 Location: Wokingham

    Based in Wokingham my client designs and delivers labelling solutions for organizations that need complete product auto-identification and lifecycle traceability. With the continual tightening of labelling regulations and audits, they empower their clients to safeguard their reputation by ensuring compliance, and significantly reduce costs by eliminating recalls through labelling errors. They are the market leader in world-class label lifecycle management, and is trusted for delivering personalized service excellence to clients in varied sectors including medical device, life sciences, healthcare, automotive, chemical and manufacturing. Based in the global headquarters, the product management function is responsible for managing the end-to-end lifecycle of the product portfolio. The Product Manager will take responsibility for understanding specific market sectors, industry drivers or opportunities, and for developing strategies to address these effectively. These will usually comprise the development of new or existing software products and propositions. The Product Manager will be responsible for ensuring market and customer requirements are captured and documented accurately, and for conveying the prioritised requirements effectively to the Development team. They will lead virtual teams in the design, costing, development and market launch of these software products, being responsible for bringing these to market on time and budget. Salary is negotiable on experience.

  • QC Senior Technologist

    Salary: £34000 Location: Salisbury

    My client is a fast-growing biopharmaceuticals company based in the South-West of England. Experts in developmental production and the bringing to market of biologicals, my client have decades of experience in production, characterisation, process and analytical validation of life saving biopharmaceuticals, including the Anthrax Vaccine. Taking on the mantle of QC Senior technologist will see you reporting directly to the QC Analytical Manager. You will be tasked to manage and perform the transfer/validation of analytical methods from Development into a GMP environment in QC Analytical Services (QCAS). The role involves all activities involved in transferring analytical methods from Development to QCAS, including running analytical methods in both Development and QCAS, writing transfer/validation protocols, executing protocols in the laboratory, writing up the associated transfer/validation reports, performing release analysis and training existing members of staff in transferred methods. Are you prepared to begin a new chapter in your career? If so, this could be the role for you.

  • Innovation Officer

    Salary: £45000 Location: Cambridge

    Based in Cambridgeshire my client is a leading biotech company specialising in Gene editing platform technology. Due to expansion they are currently looking to take on an Innovations Officer to join a diverse and energetic team. You will be responsible for liaising with the company on matters of technology transfer, IP and Patent searches. You must be approachable, friendly and have a confident manner. Ideally you will have; + PhD in Life Sciences subject (i.e Biology, Genetics, Virology, Immunology, bioinformatics etc) + Knowledge of technology transfer and Patent Searches + Basic understanding of IP The company offers great career progression and a starting salary around the £45k mark.

  • Senior Analytical Scientist in Process, Research and Development

    Salary: £42000 Location: Oxford

    Our client is a leading biopharmaceuticals organisation based from state-of-the-art offices in Oxford. Having rapidly expanded over the course of the last 3 years to over 300 employees, they are currently recruiting a wide range of biotechnology based positions. The company are at the forefront of the gene and cell therapy sector, having built a novel drug development platform which they leverage to develop products both in-house and with partners. Their proprietary portfolio of products include a lead product for Parkinson’s disease. With preparations completed for this to move into the clinic, they are in active discussions with a number of third parties to potentially out-licence the product, thereby sharing the costs and the risks whilst retaining an interest in the value of the product as it progresses. Other products at development stage include a gene-based therapies for corneal graft rejection and cancer. The company have a very respected name in the industry, and offer potential candidates a strong career path, generous financial renumeration, and a caring yet focussed environment in which to flourish. We are helping them to recruit a senior analytical scientist for their process, research and development department. Candidates should have experience with the following; + Bsc in Life-sciences or biotechnology related subject. + Strong aseptic techniques + Knowledge of general cellular, and molecular biology techniques + Practical experience of a range of bio-process analytical techniques such as cell based assays, FACS, nucleic acid extractions qPCR, SDS< Western blot, ELISA + Strong written and verbal skills Salaries for the roles are expected to be in the 38-42k range.

  • Validation Specialist

    Salary: £45000 Location: Oxford

    I am currently recruiting for a Validation Specialist to join a world-renowned biopharmaceutical company; this company specialises in developing innovative gene-based medicine and therapeutic vaccines. This exciting about has come about due to the year-on-year growth and are now in a position to bring a talented Validation Specialist to join the team in their Oxford based site. This person will support GMP manufacturing and laboratory facilities by ensuring all aspects of validation (manufacturing & laboratory equipment, facilities and utilities qualification and routine requalification activities, cleaning validation, computerised systems validation and process validation) are complete and up to date. The Validation Team also represent the business in customer audits and regulatory inspections to demonstrate compliant systems. + Ensure compliance with regulatory requirements and Quality Management System by supporting/assisting Validation Manager in performing and managing qualification and validation studies of GxP critical systems, equipment and processes. + Generate validation documentation including master plans, validation assessments and test protocols; execute qualification/validation protocols/studies + Ensure Validation Department provides timely, appropriate and expert advice on qualification and validation issues to Manufacturing, QC/QA & Engineering and other company functions as required + Supporting the validation of equipment, facilities, utilities and processes in accordance with GMP requirements and a lifecycle approach in coordination with multi-functional Validation + Represent the Validation Department during client audits and regulatory inspections ***What the Validation Specialist needs*** + Demonstrable validation experience in a biopharmaceutical, pharmaceutical or related industry including Manufacturing/Laboratory Equipment, Facilities & Utilities Qualification (URS, DQ, IQ, OQ & PQ) + Broad knowledge of biopharmaceutical and pharmaceutical industry regulations and guidelines including GMP, GDP, GLP, GEP + Experience of aseptic processing and cleanrooms highly desirable + Computer Systems Validation (CSV) would be advantageous + Educated to degree level in Science (Biological) ***What the Validation Specialist will get*** + Competitive salary + excellent benefits + Work in a fantastic state-of-the-art facility + Lots of training and development opportunities If this sounds like the perfect role for you, then please get in touch today!

  • Team Leader in Library Design

    Salary: £55000 Location: Saffron walden

    Team Leader - Library Design, Cambs, up to £60k + Management role at well-established Biotech + Antibody libraries + Interviews immediately My client are a biotechnology company located in Cambridgeshire specialising in providing protein engineering services for the discovery, identification and design of new peptide, protein and antibody compounds. We are seeking a confident Team Leader to head up an NGS platform to support lead discovery projects and line manage a small team. Youll need to evidence: + PhD / equivalent and line management + Next Generation Sequencing (NGS) for library manufacturing + Lead discovery using display technologies

  • Maintenance Engineer

    Salary: £34000 Location: Manchester

    Based in Greater Manchester my client is a leading sustainable materials company. They are real innovators in their industry and have experienced significant growth for several years. Owing to this expansion, they are currently seeking a Maintenance Engineer. Working as part of a team, the role of Mechanical Engineer will form an integral part of the business helping to support the businesses 24/7 operation. The ideal candidate will have experience working as a multi-skilled maintenance engineer within a technical manufacturing market performing PPM, reactive maintenance and troubleshooting (ideally chemical, FMCG, pharmaceuticals, or recycling background). The job is split quite evenly between electrical and mechanical engineering requirements. Candidates should have the following skills; + Appropriate qualifications in electrical/ mechanical engineering + Previous industry experience as a Multiskilled engineer The successful candidate can expect a competitive salary, generous holidays, training paid for by the company and a friendly and supportive atmosphere. In addition, there are regular opportunities for career progression for those interested in advancement.

  • Software Test Engineer / Author

    Salary: £35000 Location: Wokingham

    Based in Wokingham, my client designs and delivers labelling solutions for organizations that need complete product auto-identification and lifecycle traceability. With the continual tightening of labelling regulations and audits, they empower their clients to safeguard their reputation by ensuring compliance, and significantly reduce costs by eliminating recalls through labelling errors. Working within a team of developers and testers you will contribute to the on-going development of software products and services for both our own family of software and bespoke customer specific applications. You will be responsible for the creation of technical documents ranging from software test to installation scripts. You will need to be experienced in running and testing software to enable the creation of the required technical scripts and guides to a level acceptable to the appropriate regulatory requirements. Ideal candidates will have the following skills; + Software and testing background + Appropriate technical authoring experience + A knowledge of Medical Device and Pharmaceutical GMP requirements relating to Computer Services Validation (CSV) + Supervisory/Leadership experience desirable + ISEB / ISTQB Foundation Certificate in Software Testing + Experience of working within the GAMP V-Model + Automated software testing tools + Worked within life sciences arena Salaries for the role are expected to be in the 35k range.


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