Muskegon, Michigan, United States Hybrid / WFH Options
Cytiva
equipment qualifications, process validations, cleaning validations and computer software validations. Previous experience in root cause, corrective action, preventative action and process improvement. Understanding of ISO 9001, GoodManufacturing Practices (GMP), and Good Documentation Practices (GDP) requirements. Travel, Motor Vehicle Record & Physical/Environment Requirements: Ability to travel up to 10% a year. Must have a valid driver's license with More ❯
Nottingham, Nottinghamshire, East Midlands, United Kingdom
Compleat Food Group
standards. Lead technical and quality improvement initiatives to reduce complaints and ensure consistent compliance. Ensure robust QA team structure and shift coverage. Conduct and coordinate internal audits (systems and GMP) with timely corrective actions. Investigate and manage customer complaints and site non-conformances. Lead external audits and customer visits, ensuring full audit readiness. Collaborate with suppliers and service providers on More ❯
with diverse cultures • Necessary legal status to work in the UK. Beneficial requirements: • The closest relevant experience would be MES/EBR, eQMS, LIMS, ERP or other systems for GMP regulated manufacturers. • Experience of different project delivery methodologies including waterfall and agile • Experience of client account management • Knowledge of software delivery projects • Knowledge of Computer System Validation is an advantage. More ❯
Manchester, England, United Kingdom Hybrid / WFH Options
Factorytalk
as extensive technical training will be provided. Proven experience in leading complex MES projects from concept to deployment. Knowledge and understanding of Pharma and Biotech industry & processes. Familiarity with GMP, FDA 21 CFR Part 11, GAMP5, and other relevant regulatory requirements. Excellent problem-solving, communication, and interpersonal skills. Ability to travel as required to client sites. What We Offer: Competitive More ❯
and industry events. About You You will have extensive experience of leading Quality Improvement initiatives. Competence in investigation, root cause analysis, and risk management strategies. A deep understanding of GMP and Quality Management Systems. Strong leadership skills with the ability to inspire and motivate teams. Competence in investigation, root cause analysis, and risk management strategies. Excellent interpersonal and influencing skills More ❯
metrics in IBP context. Background in supply chain, manufacturing, or commercial operations in a regulated industry (e.g., medical devices, pharmaceuticals, healthcare) is highly desirable. Appreciation of GoodManufacturing Practices (GMP), regulatory compliance, and quality systems. Excellent stakeholder engagement and communication skills, from executive sponsors to end users. Proven ability to translate technical concepts into business value and decision-making frameworks. More ❯
of operations at each site Qualifications Qualifications & Experience M.S. degree or PhD within biotechnology, pharmacy, engineering or similar Preferrable a minimum 10 years of experience within pharmaceutical industry (with GMP knowledge; FDA, EMA, MHRA) and IT systems including: Experience with implementation and/or change management of global IT systems within the life science domain. Experience presenting in regulatory inspections More ❯
Telford, Shropshire, West Midlands, United Kingdom
TEAMWORK PARTNERSHIP LTD
and quality management systems. Manage internal and external audits, ensuring timely resolution of non-conformances. Investigate quality issues and customer complaints, driving root cause analysis and corrective actions. Champion GMP improvements and lead initiatives to enhance site-wide quality culture. Requirements What Were Looking For Proven experience in a QA leadership role within food manufacturing. Strong people management skills with More ❯
and integrate MES solutions. Experience with MES platforms such as PMX, PharmaSuite (Rockwell), Syncade-DeltaV MES (Emerson), Werum PAS-X, or similar is strongly preferred. Additional Preferences Understanding of GMP regulations and Computer System Validation (CSV) principles (e.g., GAMP 5, 21 CFR Part 11, Annex 11). Experience authoring and validating Master Batch Records (MBRs) in a regulated environment. Strong More ❯
and integrate MES solutions. Experience with MES platforms such as PMX, PharmaSuite (Rockwell), Syncade-DeltaV MES (Emerson), Werum PAS-X, or similar is strongly preferred. Additional Preferences Understanding of GMP regulations and Computer System Validation (CSV) principles (e.g., GAMP 5, 21 CFR Part 11, Annex 11). Experience authoring and validating Master Batch Records (MBRs) in a regulated environment. Strong More ❯
and integrate MES solutions. Experience with MES platforms such as PMX, PharmaSuite (Rockwell), Syncade-DeltaV MES (Emerson), Werum PAS-X, or similar is strongly preferred. Additional Preferences Understanding of GMP regulations and Computer System Validation (CSV) principles (e.g., GAMP 5, 21 CFR Part 11, Annex 11). Experience authoring and validating Master Batch Records (MBRs) in a regulated environment. Strong More ❯
and integrate MES solutions. Experience with MES platforms such as PMX, PharmaSuite (Rockwell), Syncade-DeltaV MES (Emerson), Werum PAS-X, or similar is strongly preferred. Additional Preferences Understanding of GMP regulations and Computer System Validation (CSV) principles (e.g., GAMP 5, 21 CFR Part 11, Annex 11). Experience authoring and validating Master Batch Records (MBRs) in a regulated environment. Strong More ❯
and integrate MES solutions. Experience with MES platforms such as PMX, PharmaSuite (Rockwell), Syncade-DeltaV MES (Emerson), Werum PAS-X, or similar is strongly preferred. Additional Preferences Understanding of GMP regulations and Computer System Validation (CSV) principles (e.g., GAMP 5, 21 CFR Part 11, Annex 11). Experience authoring and validating Master Batch Records (MBRs) in a regulated environment. Strong More ❯
and integrate MES solutions. Experience with MES platforms such as PMX, PharmaSuite (Rockwell), Syncade-DeltaV MES (Emerson), Werum PAS-X, or similar is strongly preferred. Additional Preferences Understanding of GMP regulations and Computer System Validation (CSV) principles (e.g., GAMP 5, 21 CFR Part 11, Annex 11). Experience authoring and validating Master Batch Records (MBRs) in a regulated environment. Strong More ❯
and integrate MES solutions. Experience with MES platforms such as PMX, PharmaSuite (Rockwell), Syncade-DeltaV MES (Emerson), Werum PAS-X, or similar is strongly preferred. Additional Preferences Understanding of GMP regulations and Computer System Validation (CSV) principles (e.g., GAMP 5, 21 CFR Part 11, Annex 11). Experience authoring and validating Master Batch Records (MBRs) in a regulated environment. Strong More ❯
and integrate MES solutions. Experience with MES platforms such as PMX, PharmaSuite (Rockwell), Syncade-DeltaV MES (Emerson), Werum PAS-X, or similar is strongly preferred. Additional Preferences Understanding of GMP regulations and Computer System Validation (CSV) principles (e.g., GAMP 5, 21 CFR Part 11, Annex 11). Experience authoring and validating Master Batch Records (MBRs) in a regulated environment. Strong More ❯
and integrate MES solutions. Experience with MES platforms such as PMX, PharmaSuite (Rockwell), Syncade-DeltaV MES (Emerson), Werum PAS-X, or similar is strongly preferred. Additional Preferences Understanding of GMP regulations and Computer System Validation (CSV) principles (e.g., GAMP 5, 21 CFR Part 11, Annex 11). Experience authoring and validating Master Batch Records (MBRs) in a regulated environment. Strong More ❯
and integrate MES solutions. Experience with MES platforms such as PMX, PharmaSuite (Rockwell), Syncade-DeltaV MES (Emerson), Werum PAS-X, or similar is strongly preferred. Additional Preferences Understanding of GMP regulations and Computer System Validation (CSV) principles (e.g., GAMP 5, 21 CFR Part 11, Annex 11). Experience authoring and validating Master Batch Records (MBRs) in a regulated environment. Strong More ❯
and integrate MES solutions. Experience with MES platforms such as PMX, PharmaSuite (Rockwell), Syncade-DeltaV MES (Emerson), Werum PAS-X, or similar is strongly preferred. Additional Preferences Understanding of GMP regulations and Computer System Validation (CSV) principles (e.g., GAMP 5, 21 CFR Part 11, Annex 11). Experience authoring and validating Master Batch Records (MBRs) in a regulated environment. Strong More ❯
and integrate MES solutions. Experience with MES platforms such as PMX, PharmaSuite (Rockwell), Syncade-DeltaV MES (Emerson), Werum PAS-X, or similar is strongly preferred. Additional Preferences Understanding of GMP regulations and Computer System Validation (CSV) principles (e.g., GAMP 5, 21 CFR Part 11, Annex 11). Experience authoring and validating Master Batch Records (MBRs) in a regulated environment. Strong More ❯
and integrate MES solutions. Experience with MES platforms such as PMX, PharmaSuite (Rockwell), Syncade-DeltaV MES (Emerson), Werum PAS-X, or similar is strongly preferred. Additional Preferences Understanding of GMP regulations and Computer System Validation (CSV) principles (e.g., GAMP 5, 21 CFR Part 11, Annex 11). Experience authoring and validating Master Batch Records (MBRs) in a regulated environment. Strong More ❯
and integrate MES solutions. Experience with MES platforms such as PMX, PharmaSuite (Rockwell), Syncade-DeltaV MES (Emerson), Werum PAS-X, or similar is strongly preferred. Additional Preferences Understanding of GMP regulations and Computer System Validation (CSV) principles (e.g., GAMP 5, 21 CFR Part 11, Annex 11). Experience authoring and validating Master Batch Records (MBRs) in a regulated environment. Strong More ❯
and integrate MES solutions. Experience with MES platforms such as PMX, PharmaSuite (Rockwell), Syncade-DeltaV MES (Emerson), Werum PAS-X, or similar is strongly preferred. Additional Preferences Understanding of GMP regulations and Computer System Validation (CSV) principles (e.g., GAMP 5, 21 CFR Part 11, Annex 11). Experience authoring and validating Master Batch Records (MBRs) in a regulated environment. Strong More ❯
and integrate MES solutions. Experience with MES platforms such as PMX, PharmaSuite (Rockwell), Syncade-DeltaV MES (Emerson), Werum PAS-X, or similar is strongly preferred. Additional Preferences Understanding of GMP regulations and Computer System Validation (CSV) principles (e.g., GAMP 5, 21 CFR Part 11, Annex 11). Experience authoring and validating Master Batch Records (MBRs) in a regulated environment. Strong More ❯
and integrate MES solutions. Experience with MES platforms such as PMX, PharmaSuite (Rockwell), Syncade-DeltaV MES (Emerson), Werum PAS-X, or similar is strongly preferred. Additional Preferences Understanding of GMP regulations and Computer System Validation (CSV) principles (e.g., GAMP 5, 21 CFR Part 11, Annex 11). Experience authoring and validating Master Batch Records (MBRs) in a regulated environment. Strong More ❯