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 »
than 600,000 users worldwide, across use cases ranging from RIM, Regulatory/R&D and Safety use cases to Clinical, Non-clinical, Quality GxP, CMC, Pharmacovigilance, Medical Information/Medical Affairs applications and more. Our mission Our mission is to provide industry-defining implementations that are fast and intuitive 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 »
in a relevant scientific discipline - Bioinformatics, Biology, Biochemistry, Chemistry, or other relevant area. A minimum of 2 - 4+ years of experience in Quality and GxP biotechnology or pharmaceutical environment with supervisory responsibilities. Understanding through prior experience of GMP regulation and guidelines related to the conduct of early phase clinical programs 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 »
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 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 »
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 »
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 »
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 »
Cell Line Development labs through the 5S program Understand and adhere to corporate standards regarding code of conduct safety appropriate handling of materials and GxP compliance Qualifications: Bachelors Degree or Masters Degree in Cell/Molecular Biology or a related field with 5 years of relevant experience pharmaceutical industry experience 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 »
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 »
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 »
moving consumer goods and pharmaceutical industry with experience in risk management and compliance Experience with agile software development processes Experience working with Pharmaceutical Regulations (GxP) for Computer System Validation (CSV) is preferred Experience with SOX requirements is preferred Experience & understanding of Cloud Hosting Platforms (Azure), AI, Automation, Networks The role 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 »
