GMP Compliance Manager (Quality Specialist)

We are looking for a Technical Writer to strengthen our GMP documentation capabilities. In this role, you will support lab operations by creating clear, compliant, and structured documentation, enabling efficient and audit-ready processes across SOPs, QEs, and CAPAs.

Create, update, and standardize SOPs, work instructions, and process documentation Support QE and CAPA documentation across full lifecycle (investigation to effectiveness check) Ensure documentation is GMP-compliant, clear, and audit-ready Collaborate with SMEs, lab teams, and QA to capture and structure content Improve consistency and standards across documentation (“one way of writing”) Support document lifecycle in eQMS (reviews, updates, versioning) Identify gaps and drive continuous improvement of documentation quality

Experience in GMP-regulated environment (pharma, biotech, lab operations) Strong technical writing skills (SOPs, CAPA, process documentation) Understanding of quality systems (QE, CAPA, change control) Ability to translate complex processes into clear documentation Experience with eQMS systems (e.g., MasterControl, Labware LIMS) High attention to detail and structured working style Strong collaboration and communication skills Proactive mindset with focus on standardization and improvement