Quality Assurance Manager

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 Manager to join one of our partner companies, a large pharmaceutical company, leader in the field of biomedicines, where you will work in a hybrid model in Beerse for 15 months.

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:

• Responsible to integrate quality standards to mitigate failure mode risks during risk-based assessments in the asset management design reviews.
• Responsible for ensuring compliance with qualification activities.
• Responsible for reviewing and approval of qualification documents, calibration and maintenance records, certification master data.
• Responsible for review and approval of master data E6 notifications (eStream), change controls records and quality issue/investigation records, including corrections and CAPAs during execution of qualification activities and during the life cycle of the facility, system and equipment.
• Maintain a current knowledge of international regulations, guidelines and industry practices related to system qualification and system data governance
• Participate in system introduction and system change projects and assure quality and compliance aspects.
• Assuring that the qualification status is maintained during assessment and execution of changes and projects
• Ensuring that all system changes that may have impact on quality, compliance or registration, are evaluated and approved in order to execute adequate control, documentation and qualification.
• Review and approval of qualification documents such as (system level) Impact Assessment critical aspect risk assessments (General) User Requirements ((G)URS), DQ/IQ/OQ/PQ protocols & reports, QSR, Test- and traceability matrices, …for compliance to regulations, guidelines and Company procedures.
• Review and approval of Periodic System Quality Reviews (PSQR) and Area Validation Master Plans (VMPs)
• Ensuring that deviations related to systems (qualification, maintenance, calibration and/or use) with possible impact on quality and/or compliance are evaluated, thoroughly investigated and that adequate corrective and preventive actions are implemented.
• Responsible for review and approval of calibration/certification procedures, calibration rationales, calibration master forms and completed calibration records.
• Responsible for review and approval of preventive maintenance procedures and master forms.
• Responsible for review and approval of parameter lists, alarm lists and transmission lists and other documents in eSTREAM
• Responsible for review and approval of qualification / system related procedures/work instruction.
• Make sure that all deliverables out of qualification are implemented in the quality systems: SOPs, Work instructions, Calibration records, Maintenance plans, …
• Prepare for regulatory and customer inspections and act as a spokesperson for QA qualification related matters during audits.
• Interact regularly with other functional groups/departments involved in qualification projects to assure that timelines for system qualifications are met and the cross-department objectives are realized.
• Pro-actively and continuously challenge the quality of the qualification processes to improve the performance of qualification and develop and implement improvements.
• Always uses the appropriate cGxP and procedures.
• Reports incidents and deviations.
• Proposes solutions to improve compliance with cGMPs.
• Always uses the appropriate prevention rules and procedures.
• Uses the available personal and collective protection materials correctly.
• Works neat and tidy.
• Reports (near) accidents, incidents, deviations and risky situations.
• Cooperates on and suggests solutions to improve safety, health and environment.
• Participate actively on promotion campaigns, working on the safe behavior program, prevention controls.
• Addresses to other colleagues and third persons when prevention procedures are not followed or in case of unsafe behavior.

Education And Experience:

• Master Engineering, Pharmacy or equivalent degree.
• Senior: 5 years’ experience in the Pharmaceutical industry
• Thorough knowledge of pharmaceutical legislation, cGMP regulations and guidelines in the area of system qualification.
• Knowledge of the different systems used during the manufacturing process
• Strong analytical thinking, risk assessment and communication skills.
• Collaboration and teaming skills
• Mindset for innovation and optimization.
• Fluent in English and Dutch (spoken and written).
• Specific know-how of systems: Comet system for incident handling / control of change; eStream: computerized maintenance management system; TrüVault: document management system and Summit (training system).

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 Manager, Periodic System Quality Reviews (PSQR), Area Validation Master Plans (VMPs)Systems, SOP, GMP, CAPA, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated.

#Li-Cm1 #Li-Hybrid #Temporary