QA Expert

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WACKER's Wacker Biotech in Amsterdam is seeking a QA Expert to review and approve GMP documents and batch records, assess deviations, and advise the Qualified Person on batch disposition. The role leads QA projects, conducts audits, maintains the quality management system, and trains staff on GMP. Ideal candidates hold a Bachelor in Analytical Chemistry or Biochemistry, with at least 5 years in pharma QA, bilingual in Dutch and English, and ability to meet deadlines. MS Office is required; knowledge of Veeva, SAP or FDA compliance is a plus. Benefits include 30 days vacation, pension, flexible hours. Reference code 31168. To apply, tailor your CV to QA audit and release, avoid agencies, and contact Peggy Engels at Amsterdam site for details.

Do you want to take responsibility and make a difference with your work? With your expertise, we can achieve great goals together. We are WACKER - Reliable. Determined. Ambitious. As one of the world's most research-intensive chemical companies, we've been making countless products that are an integral part of your everyday life possible for over 100 years. From vegan food to resource-efficient buildings to solar cells, we develop sustainable solutions that change the future.

Wacker Biotech, as part of WACKER, is a leading global biotechnology organization specializing in the production of biopharmaceuticals. The company has outstanding technologies for the rapid, efficient and thus cost-effective production of therapeutic proteins for clinical and commercial supply. Currently it is the biggest dedicated microbial Contract Development & Manufacturing Organization (CDMO) in the world. lts four dedicated and fast-growing production sites are currently based in Germany (Halle and Jena), The Netherlands (Amsterdam) and The United States (San Diego, CA). At our Amsterdam-based center Wacker Biotech B.V. focuses on the GMPcompliant microbial based production of recombinant proteins, vaccines and live microbials as drug substance and drug product.

To strengthen our team in Amsterdam,
we are looking for you as a(n) QA Expert

For more detailed information please feel free to contact Mrs. Peggy Engels, tel. 0031 (0)20 7503 675.
Please note: Agency acquisition to this vacancy is not appreciated. 

Job responsibilities:

The Quality Assurance Expert is responsible for the review and approval of the lot package, including all batch related documentation and deviations. Based on this review and assessment he/she advises the Qualified Person on the final disposition of the batch. Furthermore he/she is responsible for the review and approval of quality records and provides input for the Quality Management Systems in place. The Quality Assurance Expert participates in project teams in representation of the Quality Assurance department, bringing quality oversight to the teams and the enforcement of the compliance with the current legislation and GMP guidelines.

The tasks of the Quality Assurance Expert include:

• Review and approval of GMP documents and master batch records;
• Review and approval of batch manufacturing and QC testing records;
• Batch release preparation;
• Handling and assessment of deviations and change controls;
• Participation in project teams as QA project lead and contact person for clients;
• Execution of internal audits according to audit plan and support during external audits (clients and governmental bodies);
• Coordination and maintenance of quality management systems;
• raining of employees with regards to GMP matters.
   

Qualifications required:

For the position of Quality Assurance Expert we require a minimum of education of Bachelor degree in the orientation of Analytical Chemistry, (Micro)Biology, Biochemistry of Pharmaceutical Sciences.

• A minimum of 5 years experience in the pharmaceutical industry, preferably in QA;
• Excellent verbal and written communication skills;
• Ability to work with tight deadlines and handle multiple tasks;
• Computer fluency in MS Office, e.g. Word, Excel, PowerPoint. Knowledge of Veeva and SAP is a plus;
• Experience with FDA compliance is a plus;
• Profound knowledge of Dutch and English language, verbal and written;
• You reside in and are eligible to work in The Netherlands (valid work permit).

What do we offer?

• Employment: A challenging and international position in a professional and informal working environment
• Compensation: Attractive salary, holiday allowance, home-office travel allowance, participation in the company's success, subsidized pension plan
• Work-life balance: Flexible working hours (where possible), 30 days of vacation
• Versatile development opportunities: Support for professional development, access to online learning platform GoodHabitz

As an international company, we welcome the diversity of people. We consciously promote equal opportunities and a diverse, inclusive culture in our teams - this is what makes us successful.

We look forward to receiving your application!

Reference Code: 31168