Services · Operational QA Support
Overdue PQRs, a backlog of deviations, CAPAs that nobody has time for, and no one free to work through them reliably. A&O Pharma takes on your operational QA work, with named contacts and statutory roles in-house (Qualified Person under § 14 AMG, Head of Quality Control, Head of Production), so your processes stay under control and your team has room to breathe again.
No obligation, in confidence. We reply within one to two working days.
Every unresolved deviation and every overdue PQR is an open risk in your system, and a defective product costs more than the quality work that would have prevented it.
The question that matters
The work. We actually process deviations, CAPA, change control and Product Quality Reviews, in your system and according to your SOPs, rather than advising on how it could be done. Final approval stays with your head of quality, unless you have us fill that role as well through our interim management service. You gain capacity without blurring responsibilities, and your team has time again for the work that only they can do.
A quality management system relies on several tools that together maintain and continually improve the quality of your products. Effective, continuous quality assurance reduces quality-related costs because it avoids the cost of defective products. This only works, however, if the tools are established at every level and actually used. That is exactly where things are most often left undone in day-to-day business.
Roles we take on
Process
4 steps, one dedicated contact, no surprises.
Book an initial consultationWhat is outstanding, how old it is and what has the highest priority. Where the pressure is greatest.
Real risks first, then the finer points.
We work with your SOPs and your tools, so nothing has to be maintained twice.
Either handed back to your team, properly documented, or we keep the area running for you.
Typical starting points
The annual Product Quality Review is overdue, in some cases for several products. It is the first thing auditors look at.
Open deviations keep getting older instead of being closed. Each one is a documented risk in your own system.
Someone has left, and ongoing processes cannot wait until the position is filled.
The plan is in place, but no one has the time. Missed self-inspections are a recurring audit finding.
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
Risk Assessment and GMP Documentation
Key areas
B.Sc. Pharmaceutical Chemistry, M.Sc. Biomedical Informatics, specialisation in strategic corporate management
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
Case studies
Anonymised projects from this service: starting point, approach and outcome.
Large international pharmaceutical company
A marketing authorisation holder is planning to launch a medicinal product made in a non-EU country. We handle method transfer, EU retesting, import w...
Read the full case studyInnovative biotech company in cancer therapeutics
A research institution is setting up a GMP manufacturing facility for personalised peptide vaccines. We are supporting it from regulatory classificati...
Read the full case studyMid-sized pharmaceutical company and marketing authorisation holder
A marketing authorisation holder needed a Qualified Person (QP) for batch release and, for a period, a Head of Production. We provided both, and busin...
Read the full case studyMid-sized contract manufacturer of medicinal products
A Swiss contract manufacturer needs batch release for its authorised medicinal products after import into the EU. We release every batch on an ongoing...
Read the full case studyWe will answer your questions in an initial consultation. Dr. Olaf Mundszinger will take the time to go through them with you.
Book an initial consultationBoth. You can book individual modules, for example just the annual Product Quality Review, supplier qualification or self-inspections, or outsource your entire operational QA function on a long-term basis. In a scoping call, we agree on the set-up that fits your needs and capacity.
As a rule, we work in your system, so that records, documentation and responsibilities stay where they belong. We follow your SOPs and your document control system. If you do not yet have a suitable system, we help you set one up.
For most operational QA work (PQRs, deviations, CAPA, self-inspections, supplier qualification), a dedicated Qualified Person is not required; we provide these services independently. Where your quality system requires the involvement of the Qualified Person under § 14 AMG, we coordinate with your QP or provide one from our own team.
After a short scoping call, we usually send you a specific proposal with a timeline and a named contact within a few days. For urgent backlogs, such as open deviations with deadlines or an overdue PQR, we prioritise accordingly so that nothing is left unresolved.
Usually yes, if demand fluctuates, positions are vacant or individual routine tasks take a lot of time. You get experienced QA specialists exactly when you need them, without keeping full-time positions on the payroll permanently. In addition, effective quality assurance lowers costs because it avoids defective products. If the volume is consistently high, your own staff may make more sense, and we will discuss that with you honestly.
Overall responsibility for your quality system remains with you and your management; pharmaceutical law requires this. Unlike a staffing agency, however, we give you a named, experienced contact who can draw on the expertise of our whole company. For specialist questions, the entire team is behind them. Responsibilities and interfaces are clearly defined in the contract.
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.
