Have You known?
There is an increasing amount of quality and management tasks that are under the responsibility of the Qualified Persons in the pharma and biotech industries. The updated Annex 16 provides some more clarity and a certain potential to delegate work to qualified QA delegates. Yet, QP work load and management challenge has significantly risen. Today QPs to a much larger extent are expected to dispose of excellent management skills. We offer coaching and training programs to support your personnel in a challenging environment.
Originators, generics and medical device manufacturers as well as importers of active pharmaceutical ingredients experience an increasing need for knowledgeable QPs.
The principles of Good Distribution Practise (GDP) puts even more pressure on pharmaceutical enterprises to safeguard supply chains regarding theft-proof, safe and registration-conform transport routes. Here, support is needed, too.
We provide you with QPs and QA managers to reach your goals short and long term.
We observe an increasing demand in guidance for our customers. This requires experienced QPs who do not only securely move in an jungle of regulations and guidelines but who also dispose of extensive hands on expertise in manufacturing, QC, regulatory and increasingly organizational as well as supply chain environments.
Today efficient and lean solutions are equally important. Experienced QPs have the ability to take decisions that are regulatory proof without losing precious time. Buzz words like “lean” “right first time” “FDA readiness” “quality councils” “compliance” etc. perfectly well display the multifunctional way we move forward without neglecting ethics and regulatory principles.We partner with 6-sigma lean experts to optimise your processes to work efficiently without neglecting quality oversight.
We are strong in interim Management which is of paramount importance when it comes to optimizing processes or implementing new structures in your quality organization.
Our customers have internationally if not globally integrated processes and need Consultants with over-average cross cultural abilities.
“I have worked in Teams of colleagues from US and Latin America, Asia Pacific and Europe, high level professionals each following cGMP principles putting new processes into action. On one hand this multinational dynamics is a challenge striving for harmonised systems. At the other hand it allows to „bullet-proof“ your processes respecting regional and global guidelines.
A solid planning safeguards on-time project completion without losing regulations and drug ethics out of sight.
Multinational teams put a new challenge to specialists acting as moderators and interim managers. With international and cross cultural experiences we offer to implement processes and changes complying with company and regulatory specifications in a sustainable manner.”
- 20+ years experience in pharmaceutical, generics and biotech industries
- Plant Management experiences
- QP certificate (EU based)
- Interim Management Skills
- Cross cultural – Project Management in EU-US and Asia Pacific
Some of our customers act under time pressure. Time to market is crucial, market supply essential. Back-log Situation cannot be afforded.
We Interim Managers and QPs cope with timely Project coordination and product evaluation based on the current regulations and guidelines. We are used to deliver under time pressure.
Your goals – our commitment
We offer our services on part time and full time basis. Efficiency and adherence to regulations – joint matters.
We support projects requiring interim Management and EU-based QPs – international and cross cultural
- Interim Management
- Project Management – Trouble Shooting
- Changes – manufacturing, analytics, …
- FDA and inspection readiness programs
- QP Expertise – Annex 16
- QP Coaching and training
- GMP and GDP
- Auditing (CMO, internal inspections)
- Person-in Plant