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.

Leon Leong De Cong

R1551708

Recruit Express Pte Ltd (Healthcare & Lifesciences Division)

EA License: 99C4599