QA Support Officer (Neder-over-Heembeek, temp to perm)

14-6-2019 neder-over-heembeek
job description

- Review and approve master batch records
- Review of executed master batch records (manufacturing, packaging)
- Participate in complaint investigations,
- Ensure management of deviations: review NOE, deviations and co-ordinate investigations.
- Participate actively in investigations together with production, technical services, QC
- Review and FU of critical qualifications of production operators (gowning, VI, line clearance, mediafill)
- Quality participation in mediafill
- Provide QA support to new product introduction projects and related validation activities
- Maintain an appropriate level of compliance to Catalent QMS; review changes to QMS and assess impact to site and drive in place and in use.
- Provide support during customer audits and regulatory inspections

your contribution

- Scientific university degree (Pharmacist, Engineer or equivalent)
- At least 2 years of experience in a pharmaceutical/Bio/Medical device environment in a quality role
- Experience in working in a GMP environment is mandatory
- Very good knowledge of English and French in writing and speaking
- Good understanding of manufacturing and packaging processes is a plus
- Sterile expertise is a plus
- Demonstrable knowledge of commissioning and qualification and validation requirements is a plus
- Demonstrable experience in Deviation handling - review and approval, root cause analysis, potential product analysis.
- Team player
- Ready to work in 2 shifts (06:00-14:00 and 14:00 to 22:00),
- Ready to work in 3 shift regime to support production needs as needed

quality and environment specialist (m/f)
employment type
full time
contract type
permanent employments after interm service
Chemische en farmaceutische industrie
your Randstad contact
Laure Grauls & Kaat Meyns

office info
Leuven Diestsevest
Diestsevest 14