Pharma Consultant, Pharma Expert

A few examples of Pharma Consulting missions
I can manage for you

Expert en procédés pharma
Expert en procédés pharma
Expert en procédés pharma

For a pharma equipment or process, I can help you to:

• Lead an engineering project or accompany you in this project as a core team member

• Define with you, the best technico-commercial strategy to introduce in the pharma market a new technology or a new equipment

• Participate in technical meetings in a GAMP® methodology context, such as Design Reviews or FMEA's, in order to bring an external and independent support

• Establish a diagnosis of your process and products when troubleshooting, in order to define the real cause(s) regarding product-process-procedures, and propose curative and preventive solutions for improvements

• Improve the efficiency of an equipment

• Perform a training session to your team, focus on pharmaceutical processes, the key machine makers, the key equipments, prices and main specifications

• Audit your technical project organization and propose improvements

• Review the equipment specifications, especially for the compatibility with product requirements

• Give recommendations for the choice of vendors to contact

• Analyze the proposals made by vendors and give recommendations for additional details or verifications

• Give any constructive feed-backs on your major quality documents, such as Design Validation and FAT & SAT protocols

• Give an independent and external technical support during FAT, SAT, and Qualifications

• Or on an ad hoc basis, represent the Pharma Process Expert or Syringe Expert in key meetings with your Customers

• etc, ...

Click here to see some of the missions I have already carried out for pharma processes.

Expert en produit pharma, seringues
Expert en produit pharma, seringues
Expert en produit pharma, seringues

For a product or packaging, I can help you to:

• Lead a project for a primary or secondary packaging development, or accompany you in this project as a core team member

• Define the product or packaging specifications in order to guaranty the compatibility with the pharma standard production equipment

• Analyze a technical issue, give a diagnostic, and make recommendations for curative and preventive solutions

• Solve key deviations, such as Customer complaints or CAPA’s

• Perform a training session to your team, focus on primary and secondary packaging, the main vendors, the key products and their main specifications

• Guaranty the compatibility between the syringe technology and your product in development, whether it is for example an auto-injector or a safety device

• Define with you the best strategy for the “Go to market” regarding your product or packaging impact on the pharma production lines

• Be your main interlocutor for the technical relationships with pharma equipment manufacturers, and represent the pharma process Expert in your project team

• Participate in your key meetings, such as the Design Reviews or the risk analysis FMEA's

• Audit your technical project organization and propose improvements

• Give any constructive feed-backs on your major quality documents, such as Design Verification protocol, or Design Validation protocol

• Analyze a technical issue on a packaging, give a diagnostic, and make recommendations for curative and preventive solutions

• Or on an ad hoc basis, represent the Pharma Process Expert or Syringe Expert in key meetings with your Customers

• etc, ...

Click here to see some of the missions I already carried out for pharma products and packagings.

Expert en qualité pharma
Expert en qualité pharma
Expert en qualité pharma

For Pharma Quality aspects, I can help you to:

• Lead deviations

• Lead CAPAs (Corrective Actions and Preventive Actions)

• Lead quality audits, internal or supplier audits

• Define product, packaging and process specifications

• Manage or participate in product and process FMEA’s (Failure Mode and Effect Analysis)

• Audit PharmaCo production lines, when troubleshooting, in order to define the real cause(s) of non-quality regarding products or processes or procedures, and propose solutions and curative and preventive improvements

• Define or improve quality procedures

• Define product test protocols, perform tests and associated reports

• Perform deliverables of GAMP (Good Automated Manufacturing Practices), a quality methodology for process development, including Functional Specifications, SDS, HDS, etc ...

• Define protocols and perform Qualifications/Validations for products & packaging

• Define protocols et perform qualifications DQ, IQ, OQ, PQ for equipements (Design, Installation, Operational and Performance Qualifications)

• Educate and train operators on quality procedures and SOP's

• Propose optimisations for the best technical compatibilties between the products/packaging and the equipments of production lines,

• etc, ...

Click here to see some of the missions I already carried out for Quality aspects.

The missions are generally organized on few days, on few weeks, or on few days per month.

Of course, a confidentiality contract is signed before the mission starts.

Orders and billings are managed by a wage management company.