Quality Assurance Manager and Quality Assurance Analyst

Are you a Quality Assurance expert looking for the best of both worlds?

Would you like to work directly with a single sponsor while still enjoying the stability, global reach, and career development opportunities that come with working for a leading CRO? Our team calls it the best of both worlds, and we think you’ll agree.

ClinChoice, a fast-growing global contract research organization, is expanding its Quality Assurance team in Belgium. We’re seeking experienced Quality Assurance Managers and Specialists with a strong background in computer system validation within the pharmaceutical industry.

Are you interested in partnering with some of the world’s leading pharmaceutical companies in the field of biomedicine? If that sounds like you, we encourage you to submit your resume via our website. We're growing our network and would love to connect with you!

Quality Assurance Managers and Quality Specialists are a member of the Manufacturing Science And Technology (MSAT) Team with the dedicated focus on life cycle process validation for new and existing products.

Main responsibilities include:

• Preparing and updating process validation documents and procedures.

• Reviewing proposed changes and assessing their impact on validation.

• Leading and completing validation tasks linked to changes in products or processes.

• Improving validation processes by updating procedures and documentation.

Education and Experience:

• Degree: Master's Degree in (Bio)Sciences or Life Sciences, BS in (Bio) Sciences.

• Languages: Dutch and English

• Strong expertise on API manufacturing processes.

• Strong knowledge in validation and knowledge of statistics.

• Project management, organizing, planning and coordination skills.

• Strong mind-set and knowledge of Quality & Compliance/ regulatory requirements (GMP) in particular in the area of process validation.

• Adheres to applicable cGxP's, procedures and management systems, reports incidents and deviations.

• Proposes solutions to improve compliance with cGMP's, reporting of accidents, incidents, deviations, personal and interpersonal skills, ability to manage complexity, strict deadlines and change, interact at different levels of the organization and work under pressure.

• Effectively manage priorities and time, balance conflicting interests, stay customer- and business-focused, and anticipate technical challenges.

Specific know how of systems

The function holder is preferably acquainted with different data and production systems, such as eLIMS, truVAULT, COMET, PRX, CRB, SAP, PASx, Minitab, CPV Automation.

The Application Process

• Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

• ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.

Our Company Ethos

• Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset, and they are the fulcrum around which all ClinChoice activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.

• ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

• Keywords: Senior Clinical Research Associate, Senior CRA, Freelance, Self-employed, Contract, Site Management, Monitor, Monitoring, Complex Trials, Medical Devices, Cardiology, Neurology, Open to Travel, Submissions, Ethics, Contract Research Organisation, CRO.

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