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Wacker Chemical Senior Quality Assurance Pharma (QA) in United States
Senior Quality Assurance Pharma (QA)
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Date: Apr 12, 2024
Location: León
Company: ADL BioPharma S.L.U.
Senior Quality Assurance Pharma (QA).
Are you looking for a job in León, in a dynamic, globally active technology company – yet at the same time, you appreciate a value-oriented, trusting company? If so, we offer you an exciting job where you will be part of a global team oriented to multiculturalism and equality.
Recently, ADL BIOPHARMA and WACKER have joined forces, and now, WE ARE ONE. With this union, we are stronger, we have a worldwide presence, with production sites on three continents and almost 16,000 employees in 70 countries.
We are a leading group in the biotechnology sector, and we produce for multiple markets: food, cosmetics, fragrances... Do you want to take responsibility and make a difference with your work? With your expertise, we can achieve great goals together.
To strengthen our team in León, we are looking for you as aSenior Quality Assurance Pharma (QA).
In order to strengthen our Quality Assurance department, we are looking for people like you to fill the position Senior Quality Assurance Pharma (QA).
Your Responsibilities:
Ensure that the products of our Pharma business line meet all the necessary requirements before reaching the customer.
Exercise the pharmaceutical technical direction of the company.
Collaborate with the necessary departments to ensure that the production process and product life cycle complies with GMPs and/or applicable quality standards.
Ensure the internal and external audit program, participating in internal and external audits.
Release product batches.
Oversee the corrective and preventive action program.
Review manufacturing batch documentation.
Investigate deviations together with the teams involved and ensure proper investigation of deviations that occur.
Maintain and manage the documented information system.
Elaboration and review of reports and protocols required by the system in the field of quality (validations, qualifications, product quality reviews, technical memory, etc...).
Acting as technical interlocutor in the definition of strategic lines, applying a vision of the future and providing advice on its possible evolution.
Detection and analysis of needs, preparation of improvement proposals and risk analysis.
Ensure the application of risk analysis principles and appropriate tools for the development of the quality system throughout the product life cycle.
Track, maintain and develop system indicators to ensure process control status and product quality.
Ensure proper planning and evaluation of necessary change controls in the quality system.
Assisting authorities during inspections.
Complaint management, following up on complaints.
Preparation of regulatory documentation to be sent to the corresponding regulatory agencies.
Ensuring that manufacturing is performed in accordance with the records approved by the authorities.
Your profile
Education:
University Degree in Pharmacy
Knowledge of the application standards in accordance with the integrated management system.
Specialist knowledge of pharmaceutical GMP standards Knowledge of GMP standards.
Experience:
At least 2 years of professional experience in a similar position in the Pharma sector.
Skills:
Communication skills and ability to communicate with contracting agencies/clients.
High level of English (written and spoken).
Ability to work in interdisciplinary and international teams.
Initiative, independence and great ability to collaborate between departments.
Knowledge in the elaboration of regulatory documentation.
You can find an overview of benefits at WACKER on our careers page.
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!