1 to 25 of 30 GxP Jobs

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 »

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 »

SAP B/W4 HANA, SAP Datasphere. Ability to lead across geographies and cultures. Desirable Qualifications: Leading multiple teams across geographies. Regulatory experience, e.g. GxP and SOx. Exposure to S/4 HANA Central Finance implementations. Exposure to SAP Finance, Controlling, and integration of finance with other SAP areas like 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 »

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 »

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 »

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 »

issues. Work in close collaboration with Global Regulatory Leads and subject matter experts to ensure clinical trial deliverables are executed. Support internal and external GxP inspections. Leads project teams effectively to escalate and drive resolution of project issues. Effectively frames complex issues for decision-makers. Supports the Associate Director with 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 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 »

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 »

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 »

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 »

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 »

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 »

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 »

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 »

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 »

We need someone who has experience working in a Pharma/life science environment who has good knowledge of working in a GMP/GxP environment. This is a strategic role and requires someone who has previous regional experience with some auditing experience. The role is based from home and … for leading the output from a team of QSHE people based in the region. Key responsibilities and activities Successful client and regulatory audits of GxP activities across the EMEA sites. Timely reporting and investigation of quality and safety related incidents and audits. Added value to the business through implementing efficient … working on other Global Pharmaceutical accounts. The group is responsible for conduct of audits, training, and quality/safety investigations, all of which ensure GxP and SHE regulations are satisfied. This position is home based, however travel is expected within EMEA to visit the relevant client sites. Essential Solid grounding more »

safety sciences and related to aggregate reporting and PV writing and/or vendor management and PV quality. Experience in writing and QC of GxP relevant documents (technical writing, medical writing) Expert Knowledge of international GxP regulations and PV processes. A comprehensive understanding of pharmacovigilance, clinical development, and post-marketing … as well as writing of SOPs and maintenance of templates. Experience in working with relevant software applications (Office, SharePoint, Databases) Experienced in regard to GxP Training and Training Systems. Our Benefits CSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving more »