Services · Interim Management
If your Qualified Person under § 14 AMG, Head of Quality Control or Responsible Person under § 52a AMG is absent, you lack roles that every pharmaceutical company is legally required to have, and you can no longer release or ship product. We fill these roles at short notice with a named specialist, on site where needed, to keep your operations running.
No obligation, in confidence. We reply within one to two working days.
Without a named post-holder there is no release and no delivery, and filling the position yourself will take months.
The question that matters
Yes. The German Medicinal Products Act (AMG) requires the person to have the necessary expert knowledge, to be continuously available and to bear the responsibility personally. It does not require them to be your employee. You notify the competent authority of the appointment, and the person works on site at your facility. That is why interim management is the fastest legally sound way to deal with a vacancy: you bridge months of recruitment without release or delivery coming to a standstill.
Your company is growing, a key position is unfilled, or a statutory post-holder drops out at short notice. In the pharmaceutical industry, this is not just a staffing issue but an operational risk: without a named Qualified Person, no batch can be released, and without a Stufenplanbeauftragter (German QPPV), no one holds responsibility for pharmacovigilance. A&O Pharma provides qualified specialists to fill these roles on site at your facility, on a temporary or part-time basis.
Roles we take on
Process
4 steps, one dedicated contact, no surprises.
Book an initial consultationWhich role it is, how long it has been vacant and what authority it carries. Twenty minutes is usually enough.
We name a specialist from our own team with the required expert knowledge for exactly this role.
Where required, the change is notified to the competent authority so that the appointment is formally valid.
The person works at your facility. We help prepare the handover to your permanent appointee.
Typical starting points
A named post-holder has left, and experience shows that finding a replacement takes months. Operations cannot stand still for that long.
A key person is absent, whether planned or unexpectedly. The role must still be filled.
You are building up your organisation and need the role filled before the position has even been advertised.
The role does not justify a full-time position. A permanent hire would not be economical, and leaving it vacant is not permitted.
Responsibility
You get the name, statutory role and direct phone number of the person handling your project before the contract starts, not afterwards. A named person, not a team.
Founder and Managing Director
Key areas
Doctorate in analytical chemistry, degree in pharmaceutical sciences and chemistry
Qualified Person (QP) under § 14 AMG
Key areas
Licence to practise as a pharmacist, doctorate in pharmaceutical analysis, specialist pharmacist in pharmaceutical analysis
GMP Consulting and Training
Key areas
Licence to practise as a pharmacist
Qualified Person (QP) and Head of Quality Control
Key areas
Degree and doctorate in chemistry, postgraduate pharmacy programme to acquire the expert knowledge required under § 15 AMG
Quality Management and Sterile Manufacturing
Key areas
Degree in pharmacy, licence to practise as a pharmacist, pharmaceutical technical assistant
Qualified Person (QP) and Head of Production
Key areas
Degree in pharmacy, licence to practise as a pharmacist, doctorate in pharmaceutical chemistry
Analytical Development
Key areas
Doctorate in pharmaceutical chemistry
Regulatory Affairs
Key areas
Degree in biology with a focus on molecular biology, plant metabolic physiology and enzyme chemistry, over 20 years of experience
Regulatory Affairs
Key areas
Degree in biology with a doctorate, focus on molecular biology, biochemistry and botany, over 15 years of experience
Case studies
Anonymised projects from this service: starting point, approach and outcome.
We will answer your questions in an initial consultation. Dr. Olaf Mundszinger will take the time to go through them with you.
Book an initial consultationWe fill statutory and operationally critical positions: Head of Quality Control, Head of Production, Quality Management, Head of Quality Assurance, Qualified Person under § 14 AMG, Responsible Person for wholesale distribution under § 52a AMG, Narcotics Officer under § 6 BtMG, Responsible Person under the MedCanG, Information Officer under § 74a AMG, and Stufenplanbeauftragter (German QPPV) under § 63a AMG.
That depends on the role and your requirements. After an initial consultation, we check suitability and the legal framework and name the specific person. Cover can usually be in place within a few weeks, and often much sooner if it is urgent. Call us and we will give you a specific estimate of the timeframe for your case.
Yes. The role is held by a named person with the required qualifications, who actually performs it and bears the responsibility that comes with it. You know who holds the position, and you can contact them directly.
We then hand over to your permanent appointee in an orderly way. Interim management is designed as a bridge: we keep the role filled, both technically and legally, until your own hire takes over, and we make sure the transition is clean.
Yes, the specialist works on site. They familiarise themselves with your operation and take on the role while business continues as usual. With sites in Efringen-Kirchen and Itzehoe, we cover different regions.
You can, and you should, if the market offers a suitable candidate and you have several months' lead time. Interim management steps in when that time is not available: a statutory role is suddenly vacant, and operations cannot legally continue without it. We bridge the gap so that you do not have to make a permanent decision under pressure.
Services that are often used together
Call us or write a few lines. You will reach someone who can assess your request with real expertise.
As a member of the Life Science Nord cluster, we benefit from a strong, innovative network and work with other experts in the industry on forward-looking developments.
As a registered supplier on Scientist.com, we can also be reached through this platform: companies registered there can send their project requests directly to us.
