GMP Compliance & Quality Documentation Specialist

EngiFlex BV; Puurs-Sint-Amands; On-site; EUR 60,000 - 80,000; Full time

Job summary

EngiFlex BV seeks a QA Compliance Specialist to support quality compliance activities at a manufacturing site in Puurs, Belgium. You will help ensure that site and product-related activities align with cGxP requirements, data integrity principles, and applicable regulations.

You will contribute to the correct use of quality systems and documentation processes, review master data codes, verify information across regulatory and manufacturing systems, and assist with change control and audit

Responsibilities

• Review and approve new product codes and master data in SAP and other local systems by cross-checking regulatory, manufacturing and artwork data.
• Support the maintenance of site licences and declarations.
• Prepare and coordinate statements, certificates of analysis and other formal documents for GMP and regulatory submissions.
• Organise the legalisation and notarisation of official documents.
• Support internal and external audits as well as regulatory inspections.
• Keep assigned procedures accurate, up to date and aligned with operational needs.
• Work with archival, document management and lifecycle systems.
• Contribute to the change control process and follow up approvals with external parties.
• Help maintain the quality management system and support compliance with site quality indicators.

Job description

EngiFlex BV seeks a QA Compliance Specialist to support quality compliance activities at a manufacturing site in Puurs, Belgium. You will help ensure that site and product-related activities align with cGxP requirements, data integrity principles, and applicable regulations.

You will contribute to the correct use of quality systems and documentation processes, review master data codes, verify information across regulatory and manufacturing systems, and assist with change control and audit