Quality Assurance Specialist

Responsibilities and Key Tasks · Support the batch release process by reviewing batch documentation; · Organize QA Share Point and manage the QMS documentation and product related folders; · Organize and upload QMS and product related regulatory documents onto SharePoint as applicable; · Coordinate and perform review and update of SOPs and forms as required; · Maintain logs for QMS Matrix; · Receive, scan and file Regulatory Affairs and licensing documents related to PCC products; · Provide support for Health Authority inspections and customer audits and participate in the completion of actions as a result of inspections, audits and self-inspections; · Provide support for periodic quality management review; · Create and maintain product technical files and the respective indexes; · Review artwork for accuracy and compliance with the approved product registration; · Review and update Quality Agreements using the relevant templates as approved on site; · Provide support on recalls; · Support QMS manager to progress complaints, CAPAs, change controls and deviations/OOS results. Key Skills · Good knowledge of EU GMP & GDP, regulations and guidelines; · Understanding of Quality concepts, including Right First Time; · Highly collaborative, regular interaction with the QPs, Operations Manager, Regulatory groups, QPPV, Supply chain, site-based QA, distributors, testing labs, warehouses, sales departments, customers, MA holders and regulators; · Ability to work independently with limited supervision, self-driven, responsive and results orientated; · Good team player, positive attitude and mental agility to balance multiple activities. Qualification Requirements · Minimum a Bachelor’s degree in life science; · Minimum 3 years’ experience in a similar Quality Assurance role within the Pharmaceutical Industry; · Relevant GMP/GDP training as required to discharge assigned duties and responsibilities; · Good knowledge of MS Office; · Minimum C1 level in English and Dutch. Working Conditions · Hybrid based working environment (minimum three days a week on site); · The position will report into the site Head QP.

Location: Rotterdam and The Hague, NL

Posted Date: 7/6/2025