Quality Assurance Analyst III – Clinical Supply

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 Clinical Supply to join one of our partner companies, a large pharmaceutical company leader in the field of biomedicines, where you will work at Beerse office, until 31 December 2026.

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.  

Scope of the role:

In this role you will taking responsibility as QP delegate for the certification and release of investigational medicinal products used in worldwide clinical trials so that patient safety & compliance with applicable regulations are warranted. You will guarantee quality oversight over multiple and complex clinical supply chains for the innovative products through improving processes. Assuring close interactions with Clinical Supply Chain groups and global departments such as ECSQ, PQM and PES in order to obtain all necessary inputs for a timely release and QP certification. Supporting all CSQ release activities relating to formulation, filling, packaging, QC testing and storage of Drug Products (DP) for use in clinical trials and performing release of drug product for use in clinical trials. Serving as Quality Point of Contact for the IMP release and certification process of the assigned compounds. Thereby ensuring compliance with the GMP and GDP requirements, the clinical trial directive/regulation and other legislation related to GMP and GDP activities in a clinical trial environment.

 

Main Job Tasks and Responsibilities:

QA responsibilities:

• Support the operational quality performance.
• Act as an expert resource in assessing and maintaining quality and compliance levels.
• Continuously challenge the status quo and lead the development and implementation of breakthrough innovative initiatives that deliver sustainable improvement in organizational, quality and compliance performance.
• Represent quality on different forums and task forces.
• Ensure quality oversight of the operational activities by documented QA approval of GMP documentation and support/participation in the different quality review meetings.
• Ensure and manage the implementation and execution of the different quality system processes.
• Support the operational departments by providing coaching and/or training.
• Review of batch documentation.
• Review of analytical results.
• Regulatory Compliance Review.
• Thereby ensuring the timely review and release of clinical trial material in support of a reliable supply chain.

Support the management of quality issues/complaints:

• Ensure that deviations/complaints are timely and properly investigated such that the internal and external customer expectations are met.
• Support in-depth investigations by providing technical, quality and compliance expertise.
• Escalation lead- Ensure that adequate CAPA’s are defined for investigations with potential quality impact.
• Ensure that deviations/complaints with potential impact on patients and/or product supply are properly escalated.

Support the management of inspections/audits:

• Support the preparation, execution and follow-up of inspections and audits.
• Act as a quality spokesperson during inspections/audits.
• Ensure and support the execution and reporting of internal audits according to the internal audit plan.

Continuous improvements:

• Defines opportunities for process improvements and develops business cases and drives implementation.
• Lead/Cooperate on Process Improvements within the QA Release Organization together with the business partners.
• Participates and provides appropriate GMP support to assigned cross-functional work groups.

Responsibilities:

• Responsible for its own contribution with regard to safety, health, environment and sustainability and also addresses others about their undesirable behavior.
• Follow the prevention rules and procedures.
• Use and take care of the available protective equipment.
• Participate actively in promotional or awareness campaigns regarding prevention.
• Report immediate accidents, incidents, damage and abnormal, unsafe, unhealthy or environmentally harmful actions and situations to the senior staff.
• Ensuring order and cleanliness.
• Contribute to and propose solutions to prevent unsafe, unhealthy and environmentally damaging conditions (e.g. suggestion forms, participation in accident investigation and core committee Prevention).

Delegate QP responsibilities:

• Support the QP as legal responsible for all IMPs released by the different Company sites worldwide, used in clinical trials and sponsored by Company, as outlined in:
• Annex 16 ‘Certification by a QP and Batch Release’ to the EU guide to GMP.
• EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines.
• Directive 2001/83/EC ‘Medical products for human use’.
• Clinical Trials Regulation (Regulation (EU) No 536/2014).
• Act of May 7, 2004, on experiments on human subjects.
• Royal Decree of June 30, 2004, establishing implementing measures for the Act of May 7, 2004, on experiments on human subjects, with regard to clinical trials of medicinal products for human use, whether manufactured by the company or by third parties.
• Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products dd. 22 May 2018.
• Medical Device Regulation 2017/745.
• Support the QP as legal responsible for all IMPs manufactured by the different EU Company sites, but intended for export.
• Ensure that each batch of IMP has been manufactured in compliance with:
• Commission Directive (EU) 2017/1572 of 15 September 2017 supplementing Directive 2001/83/EC of the European Parliament and of the Council as regards the principles and guidelines of good manufacturing practice for medicinal products for human use.
• The Product Specification File (PSF).
• The information of the Clinical Trial Application (CTA).
• Ensure that all QP activities are aligned with the IMP license of Company R&D, covering manufacturing at Company warehouse.
• Assess GMP issues from the GCP environment.
• Maintain and update detailed knowledge of the steps for which she is taking responsibility.
• Prove continuous training regarding the product type, production processes, technical advances and changes to GMP.

Education and Experience:

• Certified Industrial Pharmacist with 5 years cross functional experience in the pharmaceutical industry.
• In-depth understanding of pharmaceutical product development, qualification, manufacturing, packaging, validation, testing, release, storage and distribution processes.
• Up-to-date knowledge and in-depth understanding of relevant pharmaceutical legislation, legislations related to Clinical Trials and cGMP and GDP regulations (Eudralex, ICH, Ph.Eur., USP, etc) at global, regional and national levels.
• Strong analytical thinking, decision-making and leadership skills.
• Excellent verbal and written communication skills to negotiate and communicate with external and internal customers and partners.
• Fluent in English and Dutch (spoken and written).
• Specific know how of the following systems: SAP; RIMS/TruVAULT; Summit; Trackwise; COMET; eLIMS; MS Office.

 

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 Clinical Supply, Quality Management System, Quality Performance, GMP guidelines, CAPA, SAP; RIMS/TruVAULT; Summit; Trackwise; COMET; eLIMS; MS Office, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated.

 

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