SEPRO PHARMENEX
PROFESSIONAL SUPPORT IN YOUR PROJECT TEAMS AND
BUSINESS UNITS – FOR PHARMACEUTICAL AND BIOTECH INDUSTRIES
Engineering | Validation | Compliance | Regulatory Affairs | Production |
Scientific Writing | Up-/Downstream & Fill Finish
Engineering
(Lead) Project Engineers/Project Manager CAPEX: Feasibility, Conceptual Design, Basic/Detail Design | Management ad Interim
Validation
Equipment qualification documentation & execution |
Support process validation, Aseptic process Simulation, cleaning/sterilization validation, CSV
Production routine
CAPA Management, Preparing SOP/WI |
Operator training, Process/Equipment change |
Management ad interim
Production facility
Layout development of complete facilities or individual production suites/side functions. Preparation of material and personnel flow diagrams, hygienic zone concept, pressure concept, X-contamination assessments.
Production equipment
Preparing URS and further engineering documentation, incorporating the interdisciplinary project members/SME/process needs.
Tendering process and technical clarification with system supplier, review of design documentation and project management up to FAT/SAT.
Process
Process mapping, conceptual design/adaption to new facilities, technical transfer, and scale-up.
Planning and execution of experiments, evaluation of results, and preparation of rationale/reports.
Engineering
Engineering of pharmaceutical and biotechnological manufacturing facilities means facing all aspects of a production process in a very early and abstract stage right before production takes place.
While requirements of various departments need to be considered all activities are carried out anytime with respect to applicable guidelines of authority bodies and the principles of GMP.
Validation
Validation is the documented evidence that a process or a part of it leads to products which comply to all requirements linked to quality and thus to efficacy and safety.
A successful validation is not one option – it is mandatory.
Thereby the efforts needed for validation may notably depend on quality and providence of the engineering stage.
Documentation
Preparation of qualification and validation documents. Review of relevant supplier documentation. Performing risk analysis.
Execution
Performing the test cases described in plans and documentation of results. Management of deviations.
Reporting
Evaluation of results and creation of qualification and validation reports.
Production Routine
- Head of Manufacturing ad interim
- SOP – Preparing, adaption, and training of SOPs and Work Instructions
- Planning and realization of Compliance projects
- Preparation and execution of process changes including Quality Risk Assessment
- Preparation and Assessment of Changes of Production Equipment
- Deviation Management, respectively CAPA & EC Management (Trackwise, Veeva)
- Annual Quality Review
- Requalification and Revalidation
Process
Trouble shooting during production; Process mapping and defining routine interventions; Preparation and execution of revalidation protocols; Batch record review
Deviation & CAPA Management
Effecting the Impact Assessments; performing the investigation and making up the Investigation Reports; Definition of CAPAs and ECs; Preparation of Risk Assessments for Production Processes…
SOPs and WIs
Preparation of comprehensible SOP for new Equipment; Revision of production SOPs and Work Instructions and adaption to established processes
References
We give support to pharmaceutical manufacturer to erect, to enlarge, or to refurbish their manufacturing capacities for Drug Substances and Drug Products in western Europe and ROW.
Our activities generally are subject to nondisclosure. Regarding our customers interests deeper insights might be given upon prior consulting the customer, and nondisclosure agreement. Please ask for.
Example Case 1: Green field
New multipurpose facility for liquid and lyophilized vials: Define Requirements, procurement process for equipment and services, monitore and communicate progress, supervision of project team, coordinate supplier and service provider, preparing engineering and qualification documentation, perform qualification for various production equipment.
Example Case 2: Routine Production
Improvement of a running filling line to achieve sterile conditions, and getting the line registered by the FDA.
Assure equipment availability for ongoing production. Bring expertise into a young team of production engineers and give support to ENG, Qual/Val, Compliance, and Production.
Example Case 3: Scientific Writing
Compiling a part of the application Dossier for marketing authorization
Edit chapter 3.2.P.2.4 – Container Closure System of Module 3 of the Common Technical Document. Document and assess the potential risk from a quality point of view by usage of polymeric single use equipment introduced into the filling process after the sterile filtrations of parenterals. Especially regarding Leachables and Extractables.
We are the team
We are a dynamic team of junior and senior professionals. All with main emphasis on pharmaceutical industry with its very specific aspects of Quality. We always stay open for changing statutory requirements, progress regulatory procedures, and technological changes.
Located in the south western part of Germany between Heidelberg and the French boarder it’s only a stone’s throw from pharma hot spots Basel region, Strasbourg, or the Rhine-Main Area with global players like Roche, Novartis, Lonza, Eli Lilly, Sanofi-Aventis, Merck, Abbott, Boehringer-Ingelheim, Fresenius.
Always seeking for both, experienced and young professionals to strengthen our team we aspire to live and foster diversity, equity, and inclusion every day.
Olivier Faber
Sr. Process & Qualification/Validation Engineer, General Manager
Johannes Axt
Jr. Process & Qualification Engineer
Markus Puschmann
Sr. Consultant Quality, Qualification & Documentation Engineer
Colaboration
We can rely on a long history of successful collaboration with partners and system suppliers for the pharmaceutical industry.
Jobs
Sepro Pharmenex – Quality, Safety, Reliability
Sepro Pharmenex unterstützt die pharmazeutischen Hersteller bei der Realisierung ihrer Vorhaben für den Aufbau, die Erweiterung oder Erneuerung der für die Herstellung von Wirkstoffen und Arzneimittel erforderlichen Einrichtungen und leistet damit einen Beitrag zur Versorgung von Patienten mit sicheren Arzneimitteln.
Partner für Dienstleistung in der pharmazeutischen und medizintechnischen Industrie.
Aktuelle Stellengesuche
Contact
Sepro Pharmenex GmbH & Co. KG
Dipl.-Ing. (FH) Olivier Faber
Lindelbrunnstr. 61
76829 Landau
Germany
Get in touch!
You are interested and would like to learn more? Do not hesitate and just send us an Email with your question.
We are pleased to personally get back to you soon.