Quality Assurance Coordinator (m/f/d)
Your responsibilities
- Ensures and performs Quality Assurance (QA) operational activities, such as review of manufacturing batch records, release documentation of batches associated with Drug Product and Drug Substance
- Manage deviations, CAPA and complaints, participate in escalation task force meetings
- Provide batch record review and BoM (Bill of Materials) approval related to biologic and parenteral products ensuring reliable and safe drug supply to patients and compliance to regulatory and cGMP requirements
- Prepare documents relevant to batch processing/shipping and market supply, e.g. CoA, CoC
- Manage and track timely compilation and review of APR/PQR as well as trending analysis of data (e.g. QC, stability) provided by the CMO (Contract Manufacturing Organization)
- Provides tracking and trending analysis/KPIs relevant to business processes
- Perform CMO site visits for batch record review and Person-in-Plant activities
- Coordinates change management activities, related documentation and propose requirements for technology transfers, process validation, cleaning validation, analytical methods validation, GDP, other CMC studies
- Review and approve changes and reports (e.g. stability, qualification, validation)
- Writes and reviews SOPs, provides QA input, review and approval of SOPs, TRDs (Technical Registration Documents) to assure regulatory compliance
- Maintains awareness of current GMP trends and supports continuous improvement within the Quality Unit
- Provides support for regulatory agency inspections and requests
Your profile
- Master’s degree in (bio-)chemistry, pharmacy or biotechnology or similar education
- Professional experience in the field of quality assurance/quality control/validation in the pharmaceutical or related industries
- Advanced knowledge and experience in (bio-)pharmaceutical subject matter areas including manufacturing of bulk, intermediates and final containers, discrepancy management, product inspection and labeling as well as contract manufacturing
- Broad experience and knowledge in the field of cGMP, GDP, QA/QC and regulatory compliance (US and other international agencies)
- Ability to propose and streamline business processes to maximize efficiencies, to resolve discrepancies and trending issues and able to adapt to changes in the organizational structure
- Strong interpersonal skills as well as ability to accomplish objectives despite obstacles and setbacks
- Excellent communication skills, good presentation and influencing skills
- Proficiency in Microsoft Office (Word / Excel / Outlook) applications
- Fluent in English is a must, knowledge of the German language is beneficial, any other languages are a plus
Your benefits
- Access to a Germany-wide network of 3,000 companies
- We will create a candidate profile containing your strengths and potential and thus increase your chance of being placed in a position
About Hays
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
Staffing process for a permanent or temporary position
- Analysis of qualifications
- Telephone or personal interview
- Contact with customers
- Contract with Hays
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1. Analysis of qualifications
We will review your application documents and carry out a detailed analysis of your professional qualification.
Your contact at Hays
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