Qmc Specialist
il y a 2 semaines
We are growing, grow with us
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity.
Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.
QMC Specialist
Your Job
Quality & Compliance services:
- Obtain & maintain perfect knowledge of applicable legislation and main quality guidelines
- Stay up to date with scientific developments relevant for the portfolio of the clients.
- Contribute to the management of the development and maintenance of PLx's Customers quality
- Assist in audits and inspections (customers, authorities)
- Participate in working meetings with clients to solve the client's issues
- Be actively involved in internal meetings with Pharmalex project teams. Acting Proactively in those meetings
- Participate in audits or diagnosis of dossiers
- Submit PSUR/PSUSA
- Control packaging and labelling texts
- Participate in archiving activities
- Comply with relevant quality procedures
Your Profile
- Successful completion of Pharmacist's diploma or a scientific Master's degree, or in some cases an adequate bachelor's degree
- 1 to 3 years of professional experience and project management experience
- Good Knowledge of English on top of Dutch. French is a plus.
- Good knowledge of European regulatory requirements for quality systems within medicinal products
- Distinctly strong service orientation
- Contentrelated experience in several relevant areas of QMC
- Ability to manage one or several projects with limited guidance
- Autonomous approach to work, flexibility and dedication
- Diplomacy, ability to communicate and fit in an international and multicultural environment
- Strong sense of responsibility, organizational skills and intrinsic motivation
- Good knowledge of the MS-Office package
Agencies only by prior agreement for the specific job opportunity.
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