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Technical Writer
Posted: 07/24/2026
Employment Type:
Contract
Job Category: Operations and Development
Job Number: 5168
Job Description
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
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
- 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.
- 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).