Description
I am looking for a QP-delegate to work for a multinational pharmaceutical company. You will be required to ensure that for IPT and/or CoE (Centre of Excellence) the activities are in compliance with cGMP, regulatory and legal requirements and products released to the market are in line with regulatory filings. The QP-delegates main task will be the insurance of the compliancy of the master batch records. Review and release of viral life vaccines regarding regulatory and legal requirements. This will contain 50% of the daily work.-Check within scope change-documentation and authorise
-Check and approve all qualification/ validation documentation
-Determine and decide upon quality and GMP requirements for new products and product introductions in line with quality procedures and guideline
-Monitor activities within scope concerning compliance and take necessary action
-Supportive role during external audit
-Ensure the validated status of GMP processes, systems and computer systems, in line with quality procedures and guideline
-Advise the departments within scope and ensure implementation of quality related knowledge, procedures and guidelines. Support continuous improvement, in line with quality procedures and guideline
-Support decision-making and enable CoE/IPT-members to retain the required level of expertise and quality
-Check and authorize SOP�´s in line with quality procedures and guideline
-Manage change control process within CoE Quality and participate in Change Request Council of MMD Oss, in line with quality procedures and guideline
-Check and approve CAPA`s and Changes (including classification of deviations)
Job requirements
-At least Bsc. in life sciences, biology, pharmacy or chemistry
-3 to 5 year`s experience in a GMP/Quality related role within Pharmacy (or closely related
-Extensive experience with batch review and release
-Good knowledge of GM
-Experience in cleanroom or sterile processes
-Good written and oral communication skills (both in English and Dutch
-MOST IMPORTANT ASPECT IS BATCH REVIEW / RELEASE OF
Please apply for more details