Northwich, Cheshire, North West, United Kingdom Hybrid / WFH Options
Dechra
re particularly keen to hear from those who have/are: Extensive Pharmaceutical Industry with hands on experience in development/quality in a GxP environment. Proven track record of implementing phase appropriate quality strategies Direct experience proving quality oversight of CDMOs Excellent working knowledge of FDA and EU GMPs more »
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 Experience working in a Pharmaceutical/ more »
serialization of medicines. - Proven project management experience. - Excellent problem-solving skills and attention to detail. - Experience working with databases and computer systems. - Familiarity with GxP environment, experience of Computer Systems Validation is a plus. - Excellent communication skills, proficient in written and spoken English. If you are having difficulty in applying more »
as indicated in applicable controlled documents, are followed Perform other duties, as assigned by management Minimum Required: 8 years in regulatory environment (experience in GXP roles) Experience & regulatory expertise of industry quality systems/standards Ability to interpret applicable regulations/standards Experience in leading process improvement initiatives Ability to more »
these in the absence of the Head of Quality. Represent QA on any risk assessment activities relating to GCP/clinical trials Complete all GXP training relevant for the role Working with the Head of Quality to ensure we are ‘Inspection Ready’, this includes the building of the GCP Inspection more »
these in the absence of the Head of Quality. Represent QA on any risk assessment activities relating to GCP/clinical trials Complete all GXP training relevant for the role Working with the Head of Quality to ensure we are ‘Inspection Ready’, this includes the building of the GCP Inspection more »
conduct site visits to ensure project completion and right first time quality is driven. Work with internal team members cross-functionally Uses technical and GXP knowledge to influence and assure Quality and Compliance in Design and develops plans for New Product Development/Post Launch/lifecycle management activities. Act more »
resolving general networking issues. Experience: Extensive IT/Commercial experience gained within a fast-paced environment? Experience of GAMP 5 and working within a GxP environment in providing superior customer service and support. Experience of working within a technical support position, covering Windows, Microsoft Office, Internet Explorer and various business more »
risk assessments. Must be familiar with the operation and engineering aspects of plant and equipment for Pharma and/or Biotech facility, knowledge of GXP systems and practices, facility services and validation. The role holder will have considerable technical knowledge and high level of expertise of the job, strong mechanical more »
a track record in Leading the HSE function across multiple companies in a Pharmaceutical environment. It is key that you have experience within a GXP/GMP environment. Purpose of the Job Health, Safety & Environment Lead and provide oversight and Global strategic leadership covering health, safety, and environment across the more »
Ensure GMP, Data Integrity, and GDP compliance, including timely training. Key Competencies: Proven track record in delivering regulatory-compliant validation strategies. Strong understanding of GxP compliance requirements. Excellent communication and issue escalation skills. Flexibility to adapt to business needs and experience with complex projects Proficiency in project planning software is more »
Controlled Drug Licence. Ensure procedure for the retention of documentation with procedures comprehensively written and understood by applicable staff. Ensure the appropriate storage of GxP documentation. Act as the primary company archivist. Ensure appropriate process in place for the recall of documents when requested. Ensure effectiveness of procedure for identification more »
techniques (essential) Knowledge of M10 method validation guidelines for PK assays or FDA guidelines for Immunogenicity. (essential) Project management experience (desirable) Experience in a GXP accredited laboratory (desirable more »
as part of a multi-disciplinary team. Key Skills and Requirements: - Experience working within a Pharmaceutical/Medical Device Quality Assurance department. - Knowledge of GxP and Quality related regulations and standards within the Pharmaceutical/Medical Device industry. - Familiarity with ISO 9001, ISO 13485, GCP is essential. - Knowledge of ISO more »
PMDA and other global regulatory agencies. Who We Are Zigzag Associates partners with companies across the entire drug discovery and development process to improve GxP Quality against global regulatory standards. We are a global, certified woman owned company who put people first and forge lasting relationships to bring deep impact more »
management up to executive level. Experience in the life-science industry required. In particular - a scale-up Biotech organisation. Experience in the delivery of GxP projects and systems. Fluency in the English language is required. If you have the experience required for this opportunity, please submit your application including a more »
opportunity to go permanent) Our client a Biotechnology Research company are currently hiring for a Labware Developer who has preferably worked in a GCP, GXP environment. Requirements; Experience with LIMS SQL Skills Understand Lab Processes The client are looking to hold interview ASAP, please apply if this role would be more »
solver who can work through complex issues • Good attention to detail • Experience of working with databases and computer systems • Experience of working in a GxP environment, experience of Computer Systems Validation Interested? Apply now for immediate consideration or contact Elias Adem on eadem@planet-pharma.co.uk We are an equal opportunities more »
projects. Provide support to other team members in accordance with experience and competencies General tasks: To ensure documentation required for statutory, H&S and GxP standards are completed and filed. Arrange contractor site inductions and enabling work to start safely. Propose ideas/initiatives for continuous Improvement to streamline, increase more »
installation work and small projects.Provide support to other team members in accordance with experience and competencies.To ensure documentation required for statutory, H&S and GxP standards are completed and filed.Arrange contractor site inductions and enabling work to start safely.Propose ideas/initiatives for continuous Improvement to streamline, increase efficiency or more »
and small projects. Provide support to other team members in accordance with experience and competencies. To ensure documentation required for statutory, H&S and GxP standards are completed and filed. Arrange contractor site inductions and enabling work to start safely. Propose ideas/initiatives for continuous Improvement to streamline, increase more »
installation work and small projects.Provide support to other team members in accordance with experience and competencies.GeneralTo ensure documentation required for statutory, H&S and GxP standards are completed and filed.Arrange contractor site inductions and enabling work to start safely.Propose ideas/initiatives for continuous Improvement to streamline, increase efficiency or more »
Slough, England, United Kingdom Hybrid / WFH Options
Parkside Recruitment
audits and contract auditors in line with the global audit plan, business model and applicable procedures · Plan, supervise, conduct, and support internal and external GxP audits · Follow-up on the development, implementation and completion of corrective and preventive actions with internal and external auditees · Maintain a tracking tool for audits … Quality System · Ensure continuous improvement and enhancement of the Quality 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 … training procedures in collaboration with other business companies and provide training in the area of expertise as assigned. 3. Inspections · Support the preparation for GxP inspections · Support the responses to Regulatory Authorities · Supervise and provide input to the corrective and preventive actions · Follow-up on the development, implementation and completion more »
Uxbridge, England, United Kingdom Hybrid / WFH Options
ISR Recruitment
in a fast-paced, agile-working environment Significant experience focusing on commercial country and product launches and being accountable Experience in the delivery of GxP projects and systems as several platforms will require GxP related changes and will be subject to Computer System Validation (CSV) Please call Edward Laing here more »
Manchester Area, United Kingdom Hybrid / WFH Options
Factorytalk
platform for Pharmaceutical and Biotech customers. This is groundbreaking work, reinventing the MES concept. So, as well as knowledge and experience of MES and GxP IT projects, you absolutely must be open to working in new ways with a flexible and creative mindset in tight collaborative teams with colleagues and … customers. Factorytalk has unique experience and know-how in creating, building, and validating GxP Apps using this modern digitalization tool. You will receive extensive training on Tulip, attain certification, and additional training on Factorytalk’s specialist App design, building, and validation methods to deliver Tulip solutions for GxP use. This more »
