Pharma Manufacturing Excellence/ Technical Writer/ Deviation Writing/ Manufacturing Expert/ Deviation Writer
2 months ago
Essential Functions
· Utilize technical writing strategies to ensure content of documentation is clear, concise, and complete.
· Author and revise technical documentation including facility and equipment SOPs, batch records, specifications, and training documents.
· Author and manage change controls as necessary to implement new procedures as well as revisions to documentation and SOPs to facilitate launch of new products.
· Participate in process and equipment testing to learn systems being documented.
· Complete deviations, CAPAs, change controls, document revisions and training activities to meet quality system requirements and timelines.
· Coordinate with operations, R&D, and quality representatives to ensure all project documentation requirements are achieved.
· Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
Requirements
· Bachelor Degree or equivalent work experience required.
· 3 or more years of relevant experience required.
· Demonstrated understanding of GMP / cGMP regulations.
· Skill in communication, written and verbal with the ability to interact with cross-functional teams.
· Proven time management skills and a strong attention to detail.
· Proven ability to manage and coordinate multiple projects in a fast-paced, highly professional environment.
· Ability to work well with others and independently.
· Able to read, understand and follow work instructions in a safe, accurate and timely manner.
· Proficiency in computer skills and experience with Microsoft Word, PowerPoint, and Excel.
If you are interested in the position, do kindly drop your most updated resume to leonleong@recruitexpress.com.sg
Thank You.
Leon Leong De Cong
R1551708
Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599
Tell employers what skills you have
Lifesciences
Technical Documentation
Usability
USP
FDA
Microsoft Excel
Strong Attention To Detail
Technical Writing
Quality System
Healthcare
ISO
GMP
TGA
UI
PowerPoint
Publishing
Microsoft Word
Manage Change
Writing Skills
Software Development
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