Quality Assurance Analyst/Engineer at ClinChoice

Geel, Flanders, Belgium -

Full Time

Start Date

Immediate

Expiry Date

30 Dec, 25

Salary

0.0

Posted On

01 Oct, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Quality Engineering, Pharmaceutical Supply Chain, Production Systems, Analytical Skills, Critical Thinking, Attention to Detail, Communication, Collaboration, Master Batch Records, Recipes, Quality Assurance Procedures, PAS-X Manufacturing Execution System, Delta-V System, API Manufacturing

Industry

Pharmaceutical Manufacturing

Description

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 an experienced Quality Engineer to work with one partner pharmaceutical companies. This is a full-time (1 FTE) position, office based in Geel, initially for a 10 month fixed term contract, with the possibility of extension. The Quality Engineer will review and approve Master Batch Records and Recipes to ensure timely production of the product portfolio of commercial APIs, while guaranteeing compliance with applicable regulations. 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: Review and approve Master Batch records for commercial API’s Review and approve Recipes, ensuring accuracy and compliance Write and/or review and approve relevant Quality Assurance procedures Provide support for smaller optimization projects and tasks within the Quality Assurance Commercial Operations team Foster and maintain strong collaborative relationships with Business and Quality partners Education, Experience and Skills: University Degree in sciences (e.g. chemistry, biology, pharmacy, information technology, engineering, etc.) Minimum of 3 years of experience in Pharmaceutical Supply Chain and/or Quality Assurance A strong understanding of production systems and their operation Proficiency with the PAS-X Manufacturing Execution System (MES) is required Familiarity with the Delta-V system is a plus Knowledge of API manufacturing is a plus Proven track record of working independently while maintaining effective communication with key stakeholders Strong analytical and critical thinking skills with a solution-orientated mindset A quality-focused mindset with a keen attention to detail 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. Key words: Quality Assurance Analyst, QA Analyst, Quality Engineer, Quality Assurance Engineer, QA Engineer, PAS-X Manufacturing Execution System, MES, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated

Responsibilities

The Quality Engineer will review and approve Master Batch Records and Recipes to ensure timely production of commercial APIs while ensuring compliance with regulations. They will also write and review Quality Assurance procedures and support optimization projects within the Quality Assurance team.