Manufacturing Expert (Deviation Writing, Technical Writer, CAPA) #HDC
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.
R1551708
Recruit Express Pte Ltd (Healthcare & Lifesciences Division)