2nd pharmacist Spits Apeldoorn

The second pharmacist in Spits Apeldoorn will support all quality related activities in Spits Apeldoorn and can be assigned as acting pharmacist when the responsible pharmacist is absent or on leave. The GDS Pharmacist is responsible for managing the statutory pharmaceutical product quality of SPITS based on the Professional Standard for Pharmaceutical Care and the GDS standard. The role has an enforcing, controlling and signalling function in the primary process. The resident pharmacist remains ultimately responsible for the pharmaceutical process and any changes to it. In the absence of the resident pharmacist (e.g., illness/holiday), the GDS Pharmacist will act as the resident pharmacist.

Responsibilities

Advise and monitor employees (especially Management Team and Quality) on current laws and regulations and on newly introduced ways of working; Oversee the QA Specialist regarding execution of quality assurance tasks; Drive continuous improvement of operations through optimal set-up of logistics chain organisation and processes, IT systems, procedures and resources; Motivate, inspire and coach employees and support them through change; Promote quality awareness and collaboration across the organisation; lead quality projects; Develop and optimise the quality management system; ensure compliance and address non-compliance; Serve as point of contact for quality questions and customer quality complaints; Authorise validation/calibration protocols for machines, equipment and software in the absence of the resident pharmacist; Assess incidental and structural deviations; initiate, align and monitor CAPAs; Authorise deblistering protocols; release packaging processes and (re)validated equipment/software; Support/host auditing bodies (e.g., regulators/certifiers/clients) in the absence of the resident pharmacist; Evaluate portfolio changes (product properties, shelf life, risk, packaging interactions); Coordinate and handle (internal) recalls and inform relevant stakeholders; Approve training records for employees in training; participate in cross-functional improvement initiatives

Requirements

Minimum 3 years of experience in a comparable role; Demonstrable experience with quality management systems and relevant pharmaceutical legislation/regulations; Experience working with auditing bodies and guiding audits; Strong leadership skills with proven experience coaching employees and leading change/process innovation; Knowledge of GDP and GMP guidelines; Knowledge of validation of equipment and software; Strong analytical skills and ability to translate plans into executable policy/ways of working; Broad knowledge of pharmaceutical products and services; Excellent communication skills with internal teams and external stakeholders; English communication in recurring meetings

Nice to have

ISO 9001 knowledge