Pharma Technical Writer – Manufacturing & Compliance

Cpl Group; Ballyerra; On-site; EUR 52,000 - 73,000; Full time

Job summary

Covalen is seeking a Technical Writer on a 12-month fixed-term contract onsite in Cork – Kinsale. You will support Pharmaceutical Manufacturing Operations and Technical groups by owning document revision and routing on the document management system and driving on-time approvals.

Responsibilities include designing and updating sampling plans for environmental monitoring, procedures, batch records, logbooks, training documentation, EH&S systems, and protocols.

Qualifications

• Experience in pharma/biopharma documentation
• Strong ability to produce clear, precise technical documents
• Excellent organizational and planning skills

Responsibilities

• Own document revision and routing on the document management system and drive on-time approvals
• Design, update sampling plans related to environmental monitoring
• Design, update and improve facility/process procedures and business processes
• Design, update and improve Manufacturing and Cleaning Batch Records
• Design, generate and update Operations Area Logbooks
• Design, generate and update Training Documentation
• Design, update and improve EH&S systems and documentation
• Design and generate Protocols across departments
• Design updates for other documentation in small molecule business
• Collaborate with Technical groups to develop key technical documents for new products and processes
• Support a dynamic Small Molecule manufacturing environment
• Develop understanding of core manufacturing principles
• Involvement in New Product Introductions
• Contribute to Continuous Manufacturing initiatives
• Support multiple manufacturing functions (Eng, Chemistry, QA, EHS)

Skills

Technical writing

Document management

Teamwork

Education

Relevant Science/Engineering 3rd level qualification

Tools

Document Management System

Job description

Covalen is seeking a Technical Writer on a 12-month fixed-term contract onsite in Cork – Kinsale. You will support Pharmaceutical Manufacturing Operations and Technical groups by owning document revision and routing on the document management system and driving on-time approvals.

Responsibilities include designing and updating sampling plans for environmental monitoring, procedures, batch records, logbooks, training documentation, EH&S systems, and protocols.