Pharma Technical Writer - GMP, Veeva & Regulatory Docs

LSC, Life Science Consultants; Cork; On-site; EUR 42,000 - 70,000; Full time

Job summary

LSC, Life Science Consultants in Cork is seeking a Technical Writer for a contract role in a biopharmaceutical environment. You will develop and manage site documentation, draft SOPs, protocols, and reports, and ensure compliance with data integrity and ALCOA principles.

You will serve as SME for Veeva Quality Documents and ComplianceWire, collaborating with cross-functional teams to accurately reflect technical and business requirements.

Qualifications

• Third level qualification in a Science or Engineering discipline or extensive relevant technical writing experience.
• Strong technical writing and document management experience within a regulated pharmaceutical or biotechnology environment.
• Experience with GMP documentation and data integrity/ALCOA principles.

Responsibilities

• Develop and continuously improve the site documentation management strategy.
• Draft, review and approve BPDs, SOPs, technical protocols and reports, forms and work instructions.
• Produce high-quality documentation in line with data integrity and regulatory requirements.
• Act as SME for Veeva Quality Documents and ComplianceWire, providing guidance to colleagues.
• Collaborate with technical SMEs and cross-functional teams to ensure accurate reflection of requirements.
• Support transition of documentation into Veeva Quality Documents and create training materials.

Skills

Technical writing

Document management

Regulated industry

Education

Science or Engineering degree

Tools

Veeva Quality Documents

ComplianceWire

Job description

LSC, Life Science Consultants in Cork is seeking a Technical Writer for a contract role in a biopharmaceutical environment. You will develop and manage site documentation, draft SOPs, protocols, and reports, and ensure compliance with data integrity and ALCOA principles.

You will serve as SME for Veeva Quality Documents and ComplianceWire, collaborating with cross-functional teams to accurately reflect technical and business requirements.