1 to 25 of 34 GxP Jobs

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 »

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 »

teams to service the client) Good understanding of the Life Sciences or Consumer Goods industry Appreciation of the requirements of operating in regulated environments (GxP, SOX) Excellent communication skills Results driven Building relationships and strengthening partnerships by focusing on exceptional client experience Concepts of financial, marketing and business strategy Business more »

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 »

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 »

Business Administrator for Veeva eQMS, oversee quality associated records and ensure these activities conform to regulatory requirements. Manage the controlled document scheme, act as GxP archivist, and deliver QA training activities. duties within Quality function. It is desirable, but not essential for the candidate to have a comprehension of basic … reports and dashboards in Veeva. Provide eQMS training to ensure competence across the business and maintain associated controlled documents. Ensure the appropriate storage of GxP documentation. Act as the primary company archivist by coordinating and preparing documentation for the offsite archive. Ensure appropriate process in place for the recall of … documents when requested. Administration of the quality assurance logs such as signature, notifications, QTA and audits. Document owner for GxP documents such as policies and the quality manual. Manage the controlled document scheme, including issuance and reconciliation. Provide information for Batch Record Review, QP certifications, Sponsor Release as and when more »

viable solutions to resolve such conflicts Appropriately balance the internal infrastructure and capabilities vs. outsourcing, while ensuring systems are in place to safeguard a GxP compliant environment Hire, develop and retain key talents and ensure adequate program, discipline and role-specific training is provided, and drive a high-performance, nimble more »

formal qualification in core engineering discipline/secondary engineering discipline is desirable Broad based knowledge and interest in engineered systems and maintenance Understanding of GxP principals Knowledge of Temperature, humidity and pressure instrument loops, supporting BMS monitored HVAC, reactor systems, stability chambers/cold rooms and room pressure cascades. Experience … Engineering Workshop Supervisor to ensure all maintenance PM plans remain relevant, are technically correct and compliant. Ensure all documentation of maintenance activities are to GxP standards both in paper-based records and the Computer Maintenance Management System and that accurate reports are generated. Work on small projects where required, including more »

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 »

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 »

with collaboration across professional and regional borders Regular experience with communication and presentations In-depth knowledge of computer systems and IT Good knowledge of GxP and guidelines within drug development Why ICON? Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only more »

review prior to ǪP release o manage Product Specification Files for ATIMP’s o complaint and recall handling • Develop, review, and approve Ǫuality and GxP related documentation. Technical Requirements • Extensive experience writing and reviewing GxP documents (including SOP’s, qualification/validation reports and batch records prior to ǪP review … to ensure good documentation, data integrity, essential GxP, quality and regulatory requirements are met. • Expert knowledge of GMP relating to sterile production, cleanrooms, aseptic technique, and hygienic requirements for sterile products • Extensive knowledge of regulatory requirements or processes that specifically apply for the manufacture and/or testing of cell more »

leading continuous improvement of quality and regulatory systems. The role will support and ensure that the site and related functions are in compliance with GxP regulations and applicable quality guidelines, including, but not limited to UK/EU/US GMP/GDP, ICH and other region specific guidance. The … tracking of site compliance commitments and follow up actions. Coordinate and support the delivery of Quality Compliance Metrics/KPIs to key stakeholders. Identify GxP trends and communicate these to relevant stakeholders. Support compliance risk management activities and implementation of risk mitigation plans. Working with the wider site functions to … procedures according to internal guidelines and UK/EU/US/ICH and other region specific guidance. Lead Quality Management Review meetings highlighting GxP areas of concern and working to support and track actions that are to be taken. Support quality related investigations, assist in the development and approval 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 »

and also actions to support others (e.g. reviews and approvals) Education & Qualifications: Life science degree level Experience: • 10 years experience in the pharmaceutical industry, GxP knowledge • Good level of skills in the use of computer based systems and applications Skills & Knowledge: Strategic/Transitional Skills • Demonstrate Continuous Learning • Interpersonal relationships more »

IT Team, reporting into the IT Automation Lead. This contract role will initially be until December 2024. Requirements: Data Integrity Knowledge Pharmaceutical Industry Experience (GxP) BMS, EMS and SCADA Systems Experience and Knowledge Knowledge of IT and OT areas Ability to understand complex application and OT asset landscape If you more »

Manage, coach and mentor more junior members of staff. Provide clear scientific and technological leadership to direct reports. Comply with all relevant safety and GxP procedures. Plan and prioritise own, and team’s work with input from senior manager when required. Involve in CRO’s selection process. Provide an oversight more »

serve as a consultant to the Clinical Development teams, providing guidance on GCP activities related to quality. Primary Responsibilities: Defining, maintaining, and monitoring the GxP Quality Management System (QMS). Making sure the QMS meets all the necessary regulatory requirements, with a strong focus on GCP compliance. Supporting and guiding … the Clinical Development teams in defining compliant procedures within GxP functions and effectively managing quality issues. Handpicking and documenting responsibilities for external contracted organizations that support the GxP activities. Keeping a close eye on the performance of the GxP service providers to ensure they meet the relevant quality standards. Taking 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 »

It would involve rolling out/implementing an already configured SAP template across Europe 3 days a week on site, but this is negotiable. GxP experience is a bonus We are looking for a talented SAP PP/QM (Production Planning/Quality Management) Consultant to join our team and more »

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 »

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 »

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 »

already configured SAP template across Europe Fluency in German in a mandatory 3 days a week on site in Switzerland, but this is negotiable. GxP experience is a bonus We are seeking a highly skilled SAP MM/WM (Materials Management/Warehouse Management) Consultant to join our team. In 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 »