Quality Assurance Project Specialist Consultant

Quality Assurance Project Specialist Consultant

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 Project Specialist- Consultant to join one of our partner companies, a large pharmaceutical company leader in the field of biomedicines, where you will work ONSITE at Ludwigshafen, Germany, 1.0 FTE for a 1 year 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 counterparts.

Main Job Tasks and Responsibilities

1. Process optimization and standardization of workflows within quality control.
2. Independent planning, execution, coordination, and tracking of QC process improvement projects including topics on budget, staffing planning, and efficiency improvements.
3. Support of the specialist units in ensuring quality and effectiveness during the implementation of project plans; serve as contact person for specialist units and coordination with stakeholders and clients on projects within and outside QC.
4. Representation of QC projects in local, global, and external committees and participation in international working groups.
5. Proactively solving challenges and problems that arise.
6. Dealing with laboratory events/exceptions such as OOS, OOT through documentation in the deviation management system and the development of CAPA measures in collaboration with the respective specialist department.
7. Support in the transfer of analytical methods and method optimization.
8. Support of product quality tests.
9. Coordination and communication with third-party laboratories, third-party manufacturers, and customers regarding analytical tests.
10. Support of the QC staff in ensuring complete, correct, and timely analyses as well as their review and evaluation.
11. Ensuring international and external environmental, health, and safety requirements.
12. Ensuring and maintaining GMP status in the QC laboratories.

Qualification

1. Scientific degree; Bachelor (with at least 5 years of professional experience) or Master (with at least 2 years of professional experience).
2. Experience in analytical sciences/pharmaceutical analysis.
3. Experience in the evaluation of analysis results and analytical test methods.
4. Experience in working with internal/external and national/international colleagues and committees.
5. Management experience desired.
6. Very good knowledge in the field of validated analysis systems.
7. Good IT skills (MS Office, LIMS, SAP, TrackWise).
8. Strong communication and teamwork skills.
9. Structured and independent way of working and organizational skills.
10. Reliability and maximum accuracy at work.
11. Good knowledge of English.

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 a 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.

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. 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 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, GMP, CAPA, Engineering Qualifications, Trackwise.