Position: Technical Writer - Technical Services
Department: Technical Services
Reports to: Associate Manager, Technical Services
* Interact with technical associates/scientists/leads from
Technical Services, Product
Development and other departments to create product development
protocols and reports, development and GMP Batch Records (solid,
semisolid and liquids
dosage forms),investigations, CAPAs, change controls, scale up
documents, etc. with a
strong emphasis on the following pharmaceutical processes
milling, fluid bed granulation/drying, single and bi-layer
coating, and packaging).
* Responsible to oversee and own the control of document
templates to assure cGMP and
document standards are maintained and consistent across processes.
* Update and revise batch records, protocols, and all IQ/OQ/PQ
templates to remove
redundancies, improve compliance and to ensure that documents
are user friendly and
* Support the department Head for process validation activities.
* Prepare, write, update and maintain divisional/departmental
SOPs where applicable,
including the preparation of any forms or attachments that may
accompany the SOP.
* Ability to research and understand the new equipment through
user manuals to create
SOP, IQ/OQ/PQ documents for equipment qualification program.
* Ability to write documents for eCTD filling as per FDA guidance.
* Other duties as assigned.