Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….
ClinChoice, is searching for a Quality Assurance Analyst to join one of our partner companies, a large pharmaceutical company leader in the field of biomedicines. You will be required to work on-site daily in Beerse, Belgium 1.0 FTE, 4 months contract.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.
Main Job Tasks and Responsibilities:
- Assure that all CSV related regulatory requirements are fulfilled during the complete life cycle (concept, project, operational and retirement phase) for computerized systems.
- Review and approve CSV documents such as SOPs, user requirements, impact/risks analysis’s, Validation Plans, tests, etc…) in order to maintain compliance to regulations, guidelines, policies and standards.
- Be part of IT/engineering teams and interact with other groups for the introduction of new systems and processes. To give advice and support for the preparation of CSV related activities and guard the cGMP aspects in new projects.
- Address and follow-up of deviations occurred during execution of CSV activities.
- Evaluate the incidents related to CS and propose corrective/preventive actions if necessary. Identify possible impact on the product quality.
- Provide periodic reports on quality system compliance.
- Prepare for system audits and inspections.
- Follow-up activities related to CSV resulting from (internal and external) audits, quality system initiatives.
- Maintain a current knowledge of international regulations, guidelines and new evolutions related to CSV. Implement this knowledge to maintain and improve Computerized Systems Validation.
Education and Experience:
- Bachelor’s degree or higher in Biochemistry, Biology, Pharmaceutical degree or relevant education.
- Depending on education, 3-6 years of experience in a GMP regulated environment (manufacturing, QA and/or QC).
- Knowledge of cGMP’s: 21CFR11, 21CFR210, 21CFR211, Directives 75/319/EEC and 2003/94/EC Volume 4 and annex 11 and related GMP Guidelines and Preambles.
- Knowledge of GAMP’s: generic and specific (Global Information Systems, IT Infrastructure Control and Compliance, A Risk-Based Approach to Compliant Electronic Records and Signatures, Validation of Laboratory Computerized Systems, Testing of GXP System).
- Knowledge of SW development and testing processes.
- Knowledge of Quality auditing
- Knowledge of Software quality metrics
- Ability to multi-task and work on a variety of projects at one time.
- Ability to work independently and work in cross-functional team environment.
- Good communication skills, good project management skills, good problem-solving skills.
- QA experience
- Fluent in English and Dutch (written and spoken)
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.
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