Accountable for ensuring all products supporting the business are compliant with internal security, risk management policies and practices, external regulatory and statutory requirements e.g. GxP, SARBOX and that Tech continuity plans are in place for all business-critical products. • Change & Release management: Manage change activity, including Software as a Service more »
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 »
A program/project management(MUST) Experience on projects/programmes dealing with Mergers, Acquisitions or Divestments (MUST) Knowledge of pharma-related IT regulation (GxP, CSV) (preferred) Experience in managing projects with cross-functional teams across different geographies Must be familiar with project metrics reporting and dashboards Experience in reporting 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 »
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 »
NC's. Timely implementation of product, process, and Quality Management System changes. Avoidance of product recalls. Compliance with approved procedures. Adherence to the QMS, GxP & Regulatory requirements. Develop, generate, and maintain documentation to support an effective and compliant QMS, including: Product Routers & Assemblies (PRA), Material (DRM) and Product Specifications Product more »
Linton, England, United Kingdom Hybrid / WFH Options
Owlstone Medical
audits) Experience/Knowledge * Suitable working knowledge within a Pharmaceutical/Medical Device QA department * Working knowledge, within Pharmaceutical/Medical Device business) of GxP and Quality related regulations and standards * Essential: ISO 9001, ISO 13485, GCP, * Desirable: ISO 21CFR Part 820, ISO17025, Clinical Trials experience, ISO13485 Lead auditor (external more »
techniques such as UV, HPLC, FTIR Will be able to demonstrate previous effective experience in a similar environment Prior experience working in a regulated GxP environment This is a fantastic opportunity for an experienced Analytical Chemist to work with a highly successful global company based in Central Belt of Scotland. more »
techniques such as UV, HPLC, FTIR Will be able to demonstrate previous effective experience in a similar environment Prior experience working in a regulated GxP environment This is a fantastic opportunity for an experienced Analytical Chemist to work with a highly successful global company based in Central Belt of Scotland. more »
IT software development lifecycles, with commercial experience of agile methodologies Experience with the implementation and maintenance of Salesforce applications and their delivery in a GxP environment working with dispersed and global teams Experienced in managing the delivery and performance of third-party vendors (primarily off-shore) with the ability to more »
london (uxbridge), south east england, United Kingdom
ISR Recruitment
IT software development lifecycles, with commercial experience of agile methodologies Experience with the implementation and maintenance of Salesforce applications and their delivery in a GxP environment working with dispersed and global teams Experienced in managing the delivery and performance of third-party vendors (primarily off-shore) with the ability to more »
IT Quality Assurance & Computer Systems Validation. Advise & support system owners, project managers or suppliers in the validation of computer systems according to internal & external GxP/GAMP specifications (eg in the field of production systems SW, SW development, MES or database systems). Independently prepare the necessary documentation & execution of more »
for CMC activities on drug substance, drug product both towards FDA and EMA is mandatory Solid experience with working in a regulated environment under GxP and with adherence to Company SOPs, policies and guidelines Updated knowledge of ICH GMP is required Excellent communication, presentation, and interpersonal skills. Self-driven and 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 »
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 »
ELISA analytical systems as well as the ability to develop and validate analytical methods using ELISA. • The ability to document laboratory information to a GXP standard and perform quality control processes. Apply: It is essential that applicants hold entitlement to work in the UK. Please quote job reference 56600 in more »
and contribute to regular staff and management meetings, as necessary. Requirements: A degree or equivalent in a relevant scientific discipline A background in a GxP environment is required Previous project management experience from the life science industry is essential Knowledge of Project Management Processes and excellent client facing skills A more »
and contribute to regular staff and management meetings, as necessary. Requirements: A degree or equivalent in a relevant scientific discipline A background in a GxP environment is required Previous project management experience from the life science industry is essential Knowledge of Project Management Processes and excellent client facing skills A more »
serialisation of medicines Problem solver who can work through complex issues. Experience of working with databases and computer systems Experience of working in a GxP environment, experience of Computer Systems Validation We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of 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 »
Outlook • High attention to detail, strong organisational skills and ability to multitask. Keywords: Planner, service, equipment, coordinator, administrator, administration, planning, scheduler, CMMS, GMP. GLP, GXP, GDP, Good Laboratory Practice, Good Manufacturing Practice, Good Documentation Practices, Manchester, Northwest, Macclesfield. VRS8731MP. Follow VRS Recruitment on LinkedIn to view all our latest vacancies 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 »
