1 to 25 of 170 GMP Jobs

Team Leader and continue to always perform as a leader within the group. You will work according to all necessary Good Manufacturing Practice (GMP), Hygiene and Health & Safety (H&S) requirements to ensure high quality products are produced in accordance with standard operating procedures (SOPs) and regulatory requirements. You will … make sure these are covered off in an acceptable and timely manner. Ensure all activities are conducted in compliance with Good Manufacturing Practice (GMP) standards Complete and review all documentation in a timely manner and ensure accuracy is maintained in line with batch right first-time targets (BRFT) Drive ...

user requirements gathering, risk assessments, validation planning and test execution. Maintain documentation including SOPs, validation records, configuration specifications and change records. Ensure compliance with GMP, GAMP 5, Annex 11, 21 CFR Part 11 and company quality procedures. Support internal audits, external audits and regulatory inspections. Project and Vendor Management Work ...

skills. - Experience dealing directly with customers on quality matters. - Excellent communication and stakeholder management skills. - The ability to work independently while managing multiple priorities. - GMP experience (desirable). - Degree or equivalent in a science, engineering or manufacturing discipline (desirable). This is an excellent opportunity for an experienced Quality Assurance ...

endpoint management solutions Experience working within a pharmaceutical, biotechnology, medical device or similarly regulated environment would be highly desirable An understanding of GxP, GMP, GAMP 5, Annex 11 and 21 CFR Part 11 would be advantageous Strong understanding of IT service management and ITIL principles Excellent analytical and troubleshooting skills ...

engaging and dealing project stake holders and work cross functionally. (E) An Understanding of CSV requirements in accordance with FDA 21CFR Part11/EU GMP Annex11 regulations and ISPE GAMP5 Guidelines (E). Validation project management (P) Familiarity of SaaS/Cloud based systems validation utilising modern CSA approach. ...

relationship between Complaint Handling, CAPA, Nonconformance and Risk Management processes Knowledge of ISO 13485 and 14971, FDA 21CFR Part 803, 820, 822, 806, EU GMP Annex 11 Proven ability to work both independently and in teams in a dynamic, fast-moving environment Good understanding of SaaS and GxP principles Ability ...

relationship between Complaint Handling, CAPA, Nonconformance and Risk Management processes Knowledge of ISO 13485 and 14971, FDA 21CFR Part 803, 820, 822, 806, EU GMP Annex 11 Proven ability to work both independently and in teams in a dynamic, fast-moving environment Good understanding of SaaS and GxP principles Ability ...

relationship between Complaint Handling, CAPA, Nonconformance and Risk Management processes Knowledge of ISO 13485 and 14971, FDA 21CFR Part 803, 820, 822, 806, EU GMP Annex 11 Proven ability to work both independently and in teams in a dynamic, fast-moving environment Good understanding of SaaS and GxP principles Ability ...

relationship between Complaint Handling, CAPA, Nonconformance and Risk Management processes Knowledge of ISO 13485 and 14971, FDA 21CFR Part 803, 820, 822, 806, EU GMP Annex 11 Proven ability to work both independently and in teams in a dynamic, fast-moving environment Good understanding of SaaS and GxP principles Ability ...

relationship between Complaint Handling, CAPA, Nonconformance and Risk Management processes Knowledge of ISO 13485 and 14971, FDA 21CFR Part 803, 820, 822, 806, EU GMP Annex 11 Proven ability to work both independently and in teams in a dynamic, fast-moving environment Good understanding of SaaS and GxP principles Ability ...

relationship between Complaint Handling, CAPA, Nonconformance and Risk Management processes Knowledge of ISO 13485 and 14971, FDA 21CFR Part 803, 820, 822, 806, EU GMP Annex 11 Proven ability to work both independently and in teams in a dynamic, fast-moving environment Good understanding of SaaS and GxP principles Ability ...

relationship between Complaint Handling, CAPA, Nonconformance and Risk Management processes Knowledge of ISO 13485 and 14971, FDA 21CFR Part 803, 820, 822, 806, EU GMP Annex 11 Proven ability to work both independently and in teams in a dynamic, fast-moving environment Good understanding of SaaS and GxP principles Ability ...

relationship between Complaint Handling, CAPA, Nonconformance and Risk Management processes Knowledge of ISO 13485 and 14971, FDA 21CFR Part 803, 820, 822, 806, EU GMP Annex 11 Proven ability to work both independently and in teams in a dynamic, fast-moving environment Good understanding of SaaS and GxP principles Ability ...

relationship between Complaint Handling, CAPA, Nonconformance and Risk Management processes Knowledge of ISO 13485 and 14971, FDA 21CFR Part 803, 820, 822, 806, EU GMP Annex 11 Proven ability to work both independently and in teams in a dynamic, fast-moving environment Good understanding of SaaS and GxP principles Ability ...

relationship between Complaint Handling, CAPA, Nonconformance and Risk Management processes Knowledge of ISO 13485 and 14971, FDA 21CFR Part 803, 820, 822, 806, EU GMP Annex 11 Proven ability to work both independently and in teams in a dynamic, fast-moving environment Good understanding of SaaS and GxP principles Ability ...

relationship between Complaint Handling, CAPA, Nonconformance and Risk Management processes Knowledge of ISO 13485 and 14971, FDA 21CFR Part 803, 820, 822, 806, EU GMP Annex 11 Proven ability to work both independently and in teams in a dynamic, fast-moving environment Good understanding of SaaS and GxP principles Ability ...

relationship between Complaint Handling, CAPA, Nonconformance and Risk Management processes Knowledge of ISO 13485 and 14971, FDA 21CFR Part 803, 820, 822, 806, EU GMP Annex 11 Proven ability to work both independently and in teams in a dynamic, fast-moving environment Good understanding of SaaS and GxP principles Ability ...

relationship between Complaint Handling, CAPA, Nonconformance and Risk Management processes Knowledge of ISO 13485 and 14971, FDA 21CFR Part 803, 820, 822, 806, EU GMP Annex 11 Proven ability to work both independently and in teams in a dynamic, fast-moving environment Good understanding of SaaS and GxP principles Ability ...

relationship between Complaint Handling, CAPA, Nonconformance and Risk Management processes Knowledge of ISO 13485 and 14971, FDA 21CFR Part 803, 820, 822, 806, EU GMP Annex 11 Proven ability to work both independently and in teams in a dynamic, fast-moving environment Good understanding of SaaS and GxP principles Ability ...

relationship between Complaint Handling, CAPA, Nonconformance and Risk Management processes Knowledge of ISO 13485 and 14971, FDA 21CFR Part 803, 820, 822, 806, EU GMP Annex 11 Proven ability to work both independently and in teams in a dynamic, fast-moving environment Good understanding of SaaS and GxP principles Ability ...

relationship between Complaint Handling, CAPA, Nonconformance and Risk Management processes Knowledge of ISO 13485 and 14971, FDA 21CFR Part 803, 820, 822, 806, EU GMP Annex 11 Proven ability to work both independently and in teams in a dynamic, fast-moving environment Good understanding of SaaS and GxP principles Ability ...

relationship between Complaint Handling, CAPA, Nonconformance and Risk Management processes Knowledge of ISO 13485 and 14971, FDA 21CFR Part 803, 820, 822, 806, EU GMP Annex 11 Proven ability to work both independently and in teams in a dynamic, fast-moving environment Good understanding of SaaS and GxP principles Ability ...

relationship between Complaint Handling, CAPA, Nonconformance and Risk Management processes Knowledge of ISO 13485 and 14971, FDA 21CFR Part 803, 820, 822, 806, EU GMP Annex 11 Proven ability to work both independently and in teams in a dynamic, fast-moving environment Good understanding of SaaS and GxP principles Ability ...

relationship between Complaint Handling, CAPA, Nonconformance and Risk Management processes Knowledge of ISO 13485 and 14971, FDA 21CFR Part 803, 820, 822, 806, EU GMP Annex 11 Proven ability to work both independently and in teams in a dynamic, fast-moving environment Good understanding of SaaS and GxP principles Ability ...

relationship between Complaint Handling, CAPA, Nonconformance and Risk Management processes Knowledge of ISO 13485 and 14971, FDA 21CFR Part 803, 820, 822, 806, EU GMP Annex 11 Proven ability to work both independently and in teams in a dynamic, fast-moving environment Good understanding of SaaS and GxP principles Ability ...