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.