4 of 4 GAMP Jobs

regulated industries (pharmaceutical, biotech, or medical devices). You will have a strong understanding of FDA, EMA, and GMP regulations, 21 CFR Part 11, GAMP 5 guidelines & Data integrity principles. You must also have experience of Laboratory systems such as LIMS and Chromatography Data Systems (e.g., Empower). You will ...

Wonderware), Siemens, Emerson (GE), or B&R Preferred Qualifications Bachelor's degree in Engineering, computer science or a related discipline Knowledge of GMP principles, GAMP 5 and ISA standards Experience with FactoryTalk Batch, Data Historian systems, and Microsoft SQL database designs This position may also include the following conditions: Sitting ...

/OT experience (e.g., MES/LIMS/Quality/EHS) * Solid infrastructure and security understanding, including knowledge of GxP and/or GAMP * Proven stakeholder management experience * Experience leading teams and managing external partners Guidant, Carbon60, Lorien & SRG - The Impellam Group Portfolio are acting as an Employment Business ...

overall compliance oversight for all GxP computerised systems across Pharmanovia Ensure systems comply with regulatory expectations, including EU Annex 11, 21 CFR Part 11, GAMP and MHRA data integrity guidance Develop, implement and maintain computerised systems validation and lifecycle management processes Act as the organisation’s subject matter expert … Deviation, Change Controls, Complaints, PQRs, Management Reviews, recalls, Strong knowledge of: Good Manufacturing Practice (GMP) and GxP EU Annex 11 21 CFR Part 11 GAMP 5 Data integrity principles and MHRA expectations Experience supporting or leading regulatory inspections and audits Required Skills Ability to translate complex technical and regulatory concepts ...