- 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.
- 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.
- At least 2 years of professional experience in a similar position in the Pharma sector.
- 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.
Senior Quality Assurance Pharma - León, España - Wacker
Descripción
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, 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 a Senior 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:
Your profile
Education:
Experience:
Skills:
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