Technical Writer

The Technical Writer will be a member of the Manufacturing organization responsible for the creation, revision, formatting, and maintenance of GMP documentation supporting Drug Substance and Central Services manufacturing operations. Author, edit, format, revise, and maintain SOPs, batch records, work instructions, forms, templates, and logbooks.

The Technical Writer will be a member of the Manufacturing  organization responsible for the creation, revision, formatting, and maintenance of GMP documentation supporting Drug Substance and Central Services manufacturing operations.

Responsibilities:

Documentation

• Ensure high standards of cGMP documentation practices are always adhered to.
• Author, edit, format, revise, and maintain SOPs, batch records, work instructions, forms, templates, and logbooks.
• Coordinate document reviews and approvals through the document management system.
• Manage document lifecycle activities including creation, revision, issuance, periodic review, and archival

Miscellaneous

• Ensure high standards of housekeeping are adhered to at all times.
• Ability to drive closure of assigned internal/regulatory audit items as required.
• Represent manufacturing in Project team meetings as required.
• Ensure effective liaison and communication with other departments, maintaining good relations at all times.
• Ensure that the appropriate safety policies and systems are adhered to in the GTMF suite.
• Ensure that objectives given are met in the appropriate agreed to timescale.

Requirements / Qualifications:

• 2-3 years of experience with Document management systems preferred
• Experience with CAPA preferred
• Team-working skills and communication skills.
• Motivated and detail-oriented with good problem-solving ability.
• Need to be able to read, write and understand English, and be proficient in Microsoft (Excel, Word, Outlook).