1 to 25 of 38 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 »

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 »

operates across Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Computer Systems Compliance (CSC) (together, GxP). Founded in 2007, ADAMAS has focused on ensuring that the highest standards of best practice are attained across the pharmaceutical sector. ADAMAS has an 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 »

SAP business processes/SAP security implementationsUnderstand and promote risk management activities associated with external regulations and internal Johnson & Johnson policies such as IAPP, GxP, SOX, and GDPRProvide assurance leadership on the cybersecurity risk posture of Supply Chain applications and processes, including performing and leading vendor/application assessments, design 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 »

be beneficial to your application, but is not essential: Bachelors degree (or equivalent) in a scientific or technical discipline Worked within a pharmaceutical/GxP environment in a Quality related role Familiarity with the production of solid dose oral products Management of electronic & physical documentation systems Reward For the successful 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 »

other local departments Computerised Systems Participate in system validation projects, drive the IT activities within these projects Contributes to and keeps validated state of GxP applications Coordinates inter-site communication and activities with regards to global IT systems Supports business owners during the whole life cycle of computerized systems Liaise more »

design, build, and operational support OR 3+ years in a similar role with Manufacturing OT equipment, in Healthcare/Pharma. 3+ years working with GxP and GMP environments. If you're interested and would like to find out more, reach out on LinkedIn or send your CV to lauren.mckinley@skillsalliance.com. 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 »

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 »

is delivering impactful, practice-changing evidence and is recognised as a scientific leader. You will be responsible for ensuring compliance to the ABPI code, GxP requirements and other relevant regulations related to evidence generation activities are met. Essential Skills/Experience: Degree in epidemiology or life sciences (or equivalent) Experience more »

in this location. Key Responsibilities: For this role, you will assist with compliance on all GMP/GDP and GCP regulations guaranteeing adherence to GxP and data integrity legislation. Serve as the System Owner/Administrator role for GxP IT systems that reside within QA. The ideal candidate will carry … data integrity documentation periodically and as needed. Offer aid for any other quality systems which involves Non-Conformances, CAPA, QTAs, as applicable connected to GxP IT systems. Collaborate with IT associates assuring suitable oversight of IT systems. Mediate with IT division associates linked to GxP impact and GxP compliance of … of pertinent change controls. Any other assigned duties. Requirements: Experience with TrackWise, LIMS and Documentum and/or any other QMS systems. Acquaintance global GxP, e.g., FDA CFRs, EU, 'Third countries' other than the UK. Familiarity within a pharmaceutical manufacturing, testing or quality assurance setting in a similar position. Prior 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 »

Senior GxP IT Compliance Specialist As the Senior GxP IT Compliance Specialist, you will lead compliance efforts for critical systems essential to GxP operations. Your role involves overseeing GxP IT systems from a quality assurance perspective, ensuring adherence to regulations and fostering a culture of data integrity. You'll serve … as the Data Integrity SME and contribute to maintaining and developing QMS related to IT. Key Responsibilities: Ensure ongoing compliance of GxP IT systems and processes. Support adherence to GMP/GDP and GCP regulations, including data integrity legislation. Act as System Owner/Administrator for GxP IT systems within … QA. Lead Computer System Validation and compliance processes. Review and lead compliance efforts for GxP IT system-related change controls. Provide coaching and support for data integrity adherence. Conduct periodic reviews of data integrity documentation. Assist in other quality systems as needed, such as Non-Conformances and CAPA. Collaborate with 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 »