Job title: Quality Release Officer
Department: CoE Quality (Quality Assurance)
Within the department QA, my client is looking for a quality release officer. Main purpose of the job is to support the release of IPT products. Quality review of production records, deviations and changes, release of raw materials/contact materials/intermediates/drug substances, approved qualifications/validations, approved registration documents, authorized specifications and stability-quality guarantee, completed complaints, approved Technical Quality Agreements and evaluation of Suppliers.
* Deviation handling: Able to classify all deviations that occur), in line with quality procedures and guidelines. Takes care that deviations are classified within prescribed timelines by Quality.
* Approved procedures: In line with quality procedures and guidelines check and update CJA's and SOP´s.
* Root cause investigation: In co-operation with functional areas support and check incidents investigations and customer complaints handling.
* Administration and documentation: Within the administration procedures and guidelines monitor, initiate and ensure administration and implementation of data (e.g. performance indicators) and documentation. Understanding of and insight in the historic and current status of data and documentation.
* Improvements/knowledge: In line with GMP and Merck guidelines advise the CoE's and IPT on improvement initiatives (based on conceptual insight of processes), help implementing them. Focus on continuous improvement. Give functional assignments to other Quality employees.
* Approved production records: Review Master production records (MBR, DOV, DHV, DBV). Approve Master batch records, automated production recipes and test plans. Review/Evaluate completed production batch records. Discuss and solve events related to GMP and quality together with IPT, Ware House and Procurement. Implement continuous improvement of the release- and production process related to GMP, product quality and efficiency.
* Completed events, deviations and changes: Perform risk assessments on deviations and changes related to quality and GMP. Start-up additional investigation and support root cause investigation when applicable. Approve Corrective actions or Preventive actions in consultation with Responsible Chemist. Approve events which have no impact on quality and/or GMP. Perform continuous improvement together with Production, Ware House and Procurement on release and production process.
* Release preparations for raw materials, contact materials, intermediates en drug substances: Enter and validate release results related to documentation Discuss deviations on documentation with Production, Procurement and or Supplier. Monitor progress of all ongoing releases and proactively prevent delays. Continuous improvement on release process. Build and maintain good relationship with Production and/or Suppliers in terms of quality, GMP and compliance.
* EHS Responsibility: Responsible for the realization of our corporate policy on safety, health and environment. Demonstrate personal commitment with respect to working safely, healthy and environmentally friendly.
* Educational background: HBO level analytical or biotechnical (bachelor degree by education or working experience)
* 3 years of relevant experience (Quality release in Pharma is a pre)
* Knowledge of GMP
* Lean six sigma (at least yellow belt) is a pre
* Dutch speaking
* Excellent in English
Skills & competences:
* Being able to deliver good work under pressure
* Can work with deadlines
* Strong focus on clients and quality/compliance
* Proactive/full of initiatives
* Innovative, drive to improve processes and systems, result oriented
* Being able to bring others on the same page with regard to quality mindset
* Good communication skills
Real Life Sciences
020 522 1588