QA Associate

The Quality Assurance Associate supports the continuous improvement and maintenance of the Quality Management System (QMS) within the company, under the supervision of the QA Manager, and helps to ensure that all operations comply with international cGMP regulations (e.g. Eudralex Volume 4) in general and Belgian laws and regulations in particular, as well as the company's internal standards, and assures the correct detection, reporting and closure of quality events, changes and other types of quality system related events.

This position reports to the QA Manager and will be based in Niel.

Responsibilities and Duties

The Quality Assurance Associate duties shall include, but not be limited to:

• Review and approval of the blanco batch records and batch related labels

• Perform label printing of critical labels, e.g. final product labels

• Perform batch record review & follow-up release of batches

• Prepare Batch Release certificates

• Maintaining the (electronic) Quality Management System

• QA Review & Follow up of events (including alarm handling), planned deviations, supplier complaints, OOS, CAPA, change requests

• Assist in product return and product recall

• Participation in Quality Risk Management: assess and evaluate the correctness and completeness risk assessments

• Documentation management: Revision, approval, update, storage, distribution and archiving of procedures (SOPs), quality records and files

• Establish product quality documentation system by writing and updating quality procedures

• Execution and participation on QA oversight activities, e.g. Gemba walks

• Assist in the follow-up of KPIs

• Prepare management review documentation

• Execution and participation on Internal audits

• Record meeting minutes for staff meetings and audits

• Training management:

  • Keep training files up to date and inform about training status

  • Prepare and give QA trainings

• QA Review of:

  • Environmental monitoring activities

  • Stability protocols & reports

  • Validation protocols & reports

  • Operator/process qualification

  • Visual inspection qualification

• Release of incoming materials

• Assure that good distribution practices (GDP) are applied on incoming and outgoing goods

• Release of autoclaved materials

• Prepare annual product quality reviews (PQRs)

• Assist in supplier qualification and requalification including audits

• Assist in customer qualification and requalification

• Assist in the planning and execution of the Validation Master plan

• Assist in QA related projects

• Assist in development related projects which contribute to the scientific research and development part of the organization

• Other duties as assigned

Job requirements

Education:

Bachelor degree or Master degree, by preference in biomedicine, life sciences, pharmaceutical sciences, chemistry or equivalent experience

Experience:

• Preferably of 1-3 years of relevant professional experience in Quality Assurance, preferably in pharmaceutical industry

• Knowledge of cGMP requirements and experience in the application and interpretation of cGMP requirements or equivalent e.g. ISO

Other Qualifications, Skills and Abilities:

• Analytical mind, with focus on quality and eye for detail

• Good data management skills: detail-oriented and accurate in following instructions, record keeping and completion of reports

• Scientific integrity

• Advanced written and verbal communication skills

• Well organized, well-structured, hands-on, result focused

• Able to prioritize work, to manage multiple tasks and to work under stringent timelines

• Ability to foster teamwork and a collaborative atmosphere

• Excellent interpersonal skills

• Good knowledge of English and Dutch

• Good understanding and use of MS Office (Excel, Word, PowerPoint, Outlook)

Job offer

• An exciting job in a dynamic and entrepreneurial environment with room for personal development.

• Work within an innovative environment where you can learn a lot

• Employment contract of unlimited duration with a competitive salary package.

• Working in a fun team where collaboration, growth but above all fun are central