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 [email protected]
Thank You.
Leon Leong De Cong
R1551708
Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599
