Achieving Quality Standards in the Life Science Industry

Achieving Quality Standards in the Life Science Industry

High Quality and Safety are especially important to the Life Science industry. When defects can directly lead to the endangerment of people’s or animal’s well-being, the authorities are there and ready for action. With the FDA and EMA leading the way, authorities around the world strive for the execution of the necessary quality standards. Topics such as traceability, product identification, suitable manufacturing plants, personnel and hygiene requirements. Hence, industrial companies will be audited regularly.

Accordingly, manufacturing companies from pharma/biotech, medical devices, cosmetics, food & nutrition & chemistry stand or fall with a sound quality management system, a functioning quality control and a forward-looking department for quality assurance. Also development and clinical trials are bound by strict rules and companies have to ensure compliance, otherwise they have to expect sanctions.

 

Freelancers as solution


Not surprising – yet luckily – a growing amount of professionals from these sectors decide for self-employment as a Quality Consultant. They can draw from one or two decades of experience in the industry and can call themselves experts on their field. Usually, there will be a specialization to one or two of the magic guidelines, GMP, GCP, GLP, GDP, GAMP, GVP and so forth.

Like this, the industry can benefit, if their situation requires it:

  • A manufacturer of cosmetics is looking for a Head of Production to bridge a period of 6 months
  • A chemical manufacturer needs a new system for its incoming good inspection and raw material testing
  • A pharmaceutical company is expanding its production site and needs a Qualified Person, a QA Manager and a Microbiologist as Head of QC for the daily business operations
  • A medical device company launched a FDA remediation program and needs ready-to-start specialists for CAPA & Complaints tasks
  • A biotech company does not have enough time for the qualification & validation of plants, rooms, processes
  • A CRO has too many active study sites to cover them with their own GCP Auditor
  • A wholesaler needs a new state-of-the-art GDP concept

Although the basic concept of the „good practice guidelines“ remains the same, every industry needs a freelance expert from their own line of business.

ISO10974, 10993, 11040, 11137, 11140, 11607, 11737, 12469, 12980, 13485, 13937, 14155, 14644, 14971, 15189, 15223, 15378, 21 CFR Part 11, 18001, OHSAS, 60601, SR 813.131.21….the series of numbers are endless and it is hard to find out who will match. And how to find the Consultant with the expertise with biologic process, active medical devices, sterile filling technology or the production of baby food?

Moreover, freelancers with the same skill set might be interested in different kinds of services. Interim-management, consulting, taking over only full-time or only part-time projects or carrying out the assignment on-site or 100% from the home-office.

 

The strong network of Professionals


Despite the positive development, the supply of independent consultants in life sciences won’t meet its demand without a lot of effort from both sides.

How do the right freelance quality expert and the decision-maker in the technical department find each other? Right: K-Recruiting !

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