For one of our clients in Geel, we are currently looking for a " QA Compliance Officer (HVAC)"
QA operations QC & utilities, expertise HVAC / utilities is closely linked to technical services (TS), contamination control, quality control & validation.
The department is responsible for guaranteeing the quality of the production process with a special focus on TS activities and ensuring that this is in line with the prescribed procedures, standards, business practices and legislation.
- Follow up, review & handle TS related issues (quality events, CAPAs, changes) so that they are completed compliant
- Follow up, review & handle environmental excursions (EEX) so that they are concluded compliant
- Review of trend reports, alarms, risk assessments, procedures,… with regard to EM & utilities
- Reading and interpreting documentation regarding current and new compliance standards and regulatory trends and actions
- Participate in internal & external audits and inspections
- Involvement in any QA and interdepartmental project initiatives
- Support with problem solving meetings regarding TS / contamination control related topics
Do the above responsibilities fit you like a glove?
Download your CV and motivation letter via the "apply now" button and you can expect feedback from us soon.
If something is not entirely clear, you can reach out to us by telephone off course.
- In possession of a Master in a scientific direction, or equivalent through experience
- Experience within Pharma and Quality
- Feeling with HVAC utilities, is able to work with quality systems, experience writing deviations, ...
- Experience PHENIX
- Basic knowledge and interpretation of cGLP / cGMP / cGCPs in a regulated environment
- Outstanding accuracy and attention to detail
- Independence and a strong sense of responsibility
- Interpersonal skills, an enthusiastic team player
- Good writing skills
- Good knowledge of the Dutch and English language
- A balanced salary package based on your capabilities and experience, including extra legal benefits.
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy Number: 16308