Blog Post
Just GxP Engineers Supplied Directly
- by Zener Engineering Services Ltd
- •
- 17 Jun, 2020
- •
Direct To The Experts
Zener Engineering Services (ZES) was founded on the principles of being innovative and providing world-class solutions. ZES is building a reputation for quality and excellence, with a consistently high standard of quality, reliability and versatility of its services. ZES invests heavily in highly qualified and GxP experienced personnel, to respond to the increasingly complex demands of the pharmaceutical, medical device manufacturing industries and healthcare providers.
ZES only utilise engineers who hold applicable qualifications and possess hands-on GxP experience in engineering or science. Our clients also enjoy complimentary access to the ZES senior management team, on an ad-hoc basis, during the engagement. All ZES engineers have proven experience.
ZES do not utilise dedicated sales persons, recruitment agencies or other non-engineering bodies. Come direct to the GxP Engineering experts!
ZES utilise a network of over 150 experienced GxP Engineers, who provide:
- Quality and Reliability
- Speed and Flexibility
- FDA / MHRA Experience
- Value for Money
ZES provided pharma validation services, whilst working closely with former FDA and MHRA inspectors to ensure pharmaceutical facilities reached the required standard for their first inspection.
Implementing quality systems which comply with current regulatory requirements and cGMP is an area of ZES expertise.
Implementing quality systems which comply with current regulatory requirements and cGMP is an area of ZES expertise.
Pharma Validation Services
ZES have significant experience of, and expertise in, the following pharmaceutical engineering / manufacturing aspects:
- Pharmaceutical Safety Health and Environment
- Project Management / Review
- Pharmaceutical Digital Technology
- Quality Assurance and Regulatory Issues
- Facility Design, Construction and Finishes
- Environmental Systems – HVAC, Effluent and Containment
- Services and Utilities - Steam, Water and Gases
- Liquid Products, Parenterals and Sterilisation
- Solid Dosage Forms (e.g Powder / Tablets)
- Packaging - Design and Operation
- Manufacturing Operations and Improvement
- Process Control, Automation and Data Management
- Plant Utilities, Process and Computer Systems Validation
- Cold Chain Validation
- Falsified Medicinal Products (Serialisation)
- Bespoke Training
Medical Device Validation Services
In addition to the above, ZES has significant experience of, and expertise in, the following Medical Device quality engineering / manufacturing aspects:
- All classes of Medical Device manufacturing
- Medical Device Software
- ISO 13485
- 510k Submissions : ISO 60601 : CE Marking : IEC 62304 : Technical Files etc
- ZES Director David Easton is the current Chair of the IHEEM Medical Device Technical Platform
Covid 19 Update
ZES are open and here to help you with your projects.
Whatever your requirement, ZES can provide a professional compliant engineering service,
that is streamlined and suitable for its purpose, whilst accommodating your business needs.
Whatever your requirement, ZES can provide a professional compliant engineering service,
that is streamlined and suitable for its purpose, whilst accommodating your business needs.
Contact ZES for expert help with all aspects of Pharmaceutical and Medical Device Manufacturing Engineering.
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