Quality Assurance Officer

il y a 2 jours

Leuven, Belgique Avantor Temps plein

Job Summary

Avantor, a leading global provider of products and services to customers in the biopharma, healthcare, education & government, and advanced technologies industries, is looking for a Quality Assurance Operator Private Label Chemicals to join the team in Leuven

Reporting to the Manager Quality Assurance Chemical Manufacturing in Belgium and together with your colleagues, you will be responsible for QA activities within the VWR Chemicals area of VWR International, part of Avantor and this linked to laboratory activities.
- Key tasks - major job duties & responsibilities
- Interpret and implement quality assurance standards to assure compliance with GMP, ISO 9001, (ISO 13485) and ISO 17025/34 and industry regulatory requirements.
- Draft quality assurance policies, procedures, work instructions and supporting documentation in accordance with the VWR International policy, Legal Environmental & Safety regulation, ISO14001 and OHSAS18001.
- Interact with company management, internal departments, and other sites to successfully implement and maintain Quality Systems and the accompanying document management systems.
- Evaluate adequacy of QA standards, review the implementation and efficiency of quality and set up inspection systems. Plan, conduct and supervise testing and inspection of materials and products to ensure finished product quality.
- Devise sampling procedures and directions for recording and reporting quality data. Collect, compile and analyze statistical quality data to identify areas for improvement in the quality system. Prepare reports to communicate outcomes of quality activities.
- Investigate customer complaints and/or non-conformance issues
- Develop, recommend and supervise corrective and preventive actions
- Evaluate and/or approve changes to product/equipment specifications and processes.
- Identify training needs and coordinate training interventions to meet quality standards
- Perform and document internal audits and other quality assurance activities.
- Coordinate and/or support on-site audits conducted by third parties and regulatory agency inspections. Evaluate audit/inspection findings and implement appropriate corrective actions.
- Implement and supervise risk management activities
- Ensure up to date batch records, review and approve completed batch record, analysis forms and other related production records, and complete the release of non-GMP products, support release of GMP licensed products by the Qualified Person.
- Ensure the calibration of premises and equipment.
- Regularly connect with the production team, QA, QC and Supply Chain responsible to find opportunities for quality and efficiency improvement.
- Skills, knowledge & experience
- Master or Bachelor in applied sciences or engineering
- Knowledge about ISO Quality Management standards and/or GMP.
- You have a chemical background.
- Ability to nurture partnership and teamwork across internal functions.
- Proficient in English and Dutch both written and spoken, French on an equivalent level would be helpful.
- Proficient in use of MS Office software, Excel, Word, PowerPoint, Access and SAP
- Our offer
- We offer the opportunity to work in a multifaceted environment where collaboration is key. Next to a competitive salary package in line with your qualifications and experience we offer hospital and group insurance, luncheon vouchers and a bonus scheme. Avantor's flexible time system and holiday plan allows for a phenomenal work-life balance.
- We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.
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