Services · Interim Management
When the Qualified Person under § 14 AMG, the Head of Quality Control or the Responsible Person under § 52a AMG is absent, you are missing functions that are legally required for a pharmaceutical entrepreneur, and you may no longer release or deliver product. We fill these functions at short notice, with a named specialist on site, keeping your operations running.
Non-binding and confidential. Answer in one to two working days.
Without a named individual there is no release, no delivery, and your own vacancy will not be filled for months.
The question that matters
Yes. The German Medicines Act requires that the individual holds the required expertise, is permanently available and bears the responsibility personally. It does not require that the individual be employed by you. You register the person with the competent authority, and they work on site at your facility. This is precisely why interim management is the fastest legally sound solution for vacancies: you bridge months of recruitment without release or delivery coming to a stop.
Your company is growing, a key position is unfilled, or a statutory function falls vacant at short notice. In the pharmaceutical industry, this is not merely a staffing matter but an operational risk: without a named Qualified Person, no batch may be released, and without a Graduated Plan Officer (Stufenplanbeauftragte), pharmacovigilance responsibility is missing. A&O Pharma provides qualified personnel for temporary or partial cover on site at your facility.
Process
4 Steps, a fixed contact person, no surprises.
Arrange an initial consultationWhich role, vacant since when, which authorities are needed. Twenty minutes is usually enough.
We name a specialist from within our organisation with the required expertise for this specific role.
The change is notified to the competent authority where required, so the appointment is formally valid.
The individual works at your facility. We also help prepare the handover to your permanent appointee.
Typical initial situations
A named function has left and experience shows that a replacement takes months. Operations cannot stand still for that long.
A key individual is absent, planned or unexpected. The role remains subject to mandatory staffing regardless.
You are building up structures and need the function before the position is even advertised.
The role does not fill an entire position. A permanent hire would be uneconomical, and a gap would not be permitted.
Responsibility
You get the name, the legal role and the extension of the person who takes over your topic. Before the start of the contract, not afterwards, and not as a team, but as a person.
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 analytics, specialist pharmacist for pharmaceutical analytics
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, further education in pharmacy to attain expert knowledge 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
Case studies
Anonymised projects from exactly this service, with initial situation, procedure and the final outcome.
We clarify your questions in the initial consultation. Dr. Olaf Mundszinger takes the time for it.
Arrange an initial consultationWe cover 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, MedCanG Responsible Person, Information Officer under § 74a AMG, and Graduated Plan Officer (Stufenplanbeauftragte) / QPPV under § 63a AMG.
This depends on the role and your requirements. After an initial consultation, we clarify suitability and the legal framework and name the specific individual. An orderly bridging arrangement can generally be put in place within a few weeks, often considerably faster where the matter is urgent. Call us, and we will give you a concrete estimate of the timeframe for your case.
Yes. It is a named individual with the required qualifications who genuinely performs the role and bears the associated responsibility. You know who holds the position, and that person is directly reachable.
An orderly handover to your permanent appointee then takes place. Interim management is intended as a bridge: we keep the role filled, professionally and legally, until your own hire takes over, and we ensure a clean transition.
Yes, the temporary staffing takes place on site. The specialist familiarises themselves with your operation and takes on the role within ongoing business. With locations in Efringen-Kirchen and Itzehoe, we cover different regions.
You can and should, where the market offers a suitable candidate and you have months of lead time. Interim management steps in precisely when this time is not available: a statutory role is acutely vacant, and operations must not continue without it. We bridge the gap, rather than forcing you into a permanent decision under pressure.
Services that are often used together
Call us or write three lines. You will reach someone directly who can assess your subject professionally.
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.
