Description:
TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently recruiting a CAPA & Complaint Investigator to strengthen the team of one of our clients.

Our client is a global, research-based BioPharma company dedicated to developing innovative therapies for some of the world's most complex and serious diseases. The company's mission is to significantly improve treatment options in four therapeutic areas: immunology, oncology, virology and neuroscience with its expertise, committed employees and innovative aspirations. In more than 75 countries, employees work every day to advance health care for people around the world.

Main Job Tasks and Responsibilities

• Independent investigation of exceptional events to determine the cause (Root Cause Analysis)
• Independent investigation of product complaints
• Independent preparation, review and approval of exception reports as well as independent planning. Coordinate and track corrections, corrective and preventive actions using the database
• Independent coordination of the system for GMP deviations, as well as corrective and preventive measures (CAPA)
• Fulfillment of assigned special functions such as Sample dispatch
• Contact for the specialist units on GxP-relevant issues, the exceptional events / CAPA and Complaints concern
• Maintenance of the Soltraqs database
• Support of quality control in the area of ​​CAPA and process optimisation
• Ensuring internal and external environmental protection and safety guidelines
• Ensuring the GMP status operations production areas
• Independent assurance of the implementation of new global and local requirements in the area of ​​CAPA and complaints

Education and Experience

• Natural science studies and good knowledge of the pharmaceutical environment
• Knowledge of the regulatory and legal requirements for pharmaceuticals
• Knowledge of pharmaceutical analysis
• Experience in evaluating analytical results and methods

Skills

• Very good knowledge of English

The Benefits of Working for TalentSource in Germany

• Dedicated Line Manager
• Monthly meetings with line manager
• Full performance and development process with end of year reviews
• Team events and end of year party
• Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
• Employee satisfaction survey - your feedback is important for continuous improvement

Who will you be working for?

About CROMSOURCE

CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.

Our Company Ethos

Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE 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 are evidenced by our below industry average turnover rates.

About TalentSource Life Sciences

TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role and work autonomously.

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.

If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00002370

or please contact Alexander.Sourounis@cromsource.com for more information.

CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

Keywords: CAPA & Complaint Investigator
Skills: CAPA, GMP, Pharma, Pharmaceutical, Product complaint, Quality Assurance, Regulatory Location: Germany Share:

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