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Pharmaceutical ind.

-Consultancy and service
We are your professional partner for the realization of building projects in the pharmaceutical industry. We support and advise you from the start of the project work up to the qualification of your overall plant.
We employ a team of specialists with many years' experience in quality assurance and supervision in accordance with the respective specific requirements.
We assure your needs with regard to quality, efficiency and productivity. It is our ambition to apply for you the optimum processes and resources and to continuously improve your organization and work flow.

-Engineering

-Supervision
Project preparation and implementation at home and abroad
Planning and organization
Structuring of projects
Personnel management
On-schedule provision of all necessary approvals and specifications for production and assembly

-Quality assurance and documentation
Qualitative receiving inspection and testing, combined with the release of the materials for production and assembly
Project optimation through permanent inspections
Creation of the documentation accompanying production and tests
Creation of the final documentation
Documentation acceptances with TÜV (Technical Control Board) and/or the customer
Quality assurance and supervision according to the specific requirements of FDA and GMP
Creation of test programs
Compilation of the necessary material and supervision proofs according to customer's specification

-Video endoscopy and X-ray documentation
Taking and analysis of video endoscopy photographies
Coordination and documentation of ZFP works
Analysis of radiographies and rotoscan tests

-Validstion and qualification
Prospective plant qualification:
- Clarification of the bases (URC)
- Drawing up of the validation master plan (VMP)
- Basic planning / design qualification (DQ)
- Installation qualification (IQ)
- Operation qualification (OQ)
- Performance qualification (PQ)
- Documentation of project completion

Retrospective plant qualification:
- Clarification of GMP requirements / concept finding
- Examination and evaluation of the available documentation
- Determination of the scope of qualification
- Installation qualification(IQ)
- Operation qualification (OQ)
- Performance qualification (PQ)
- Documentation of project completion

Validation:
- Process validation (PV)
- Cleaning validation (CV)
- Validation documentation

-Creation of SOP´s
Verification and revision of existing SOP's for conformity with the state of the art
Elaboration of work instructions, welding specifications and SOP'

-Material tests
Material receiving inspection
Roughness test
Verification of the material certificates
Material management

-Supervision of welding operations
Check of weld-seam preparation, welding conditions and filler materials
Check of the authorization of the executing firms
Planning and coordination of the employment of the welders
Carrying out and supervision of process, welder and work examinations
Permanent supervision of the weld-seam quality according to the specification

-Welders´ qualification
Project-related qualification of the welders and corresponding documentation

-As-build records
Qualitative inspection of the plant according to isometric drawings of the pipelines
Drawing up of the acceptance reports
Management of defects and supervision of their elimination
Performance and supervision of compression tests and service tests
Elaboration of the respective required documentation

-Training and advanced training of welders
Preparation and supervision of process tests
Holding of examinations for manual and orbital welders according to EN and ASME standards
Holding of regular training courses for manual and orbital welders

-Training for other companies (GMP and FDA)