Your Responsibilities
· Ensures Master Production Records (MPRs), Production Summaries (PS), and Master Cleaning Records (MCR) are drafted in such a manner that clearly describes the process and captures all data required in Sterling’s format and a cGMP compliant manner based on a detailed Technical Package from the Development Team or other acceptable written procedure.
· Coordinates and facilitates document Group Review meetings and tracks all documentation routing through appropriate reviewers to ensure timely flow through all required departments and publish monthly performance metrics.
· Works with multiple Project Managers and teams to establish priorities.
· Works closely with Project Managers, Technical Managers, CR&D, AR&D, QC, QA, Production and Manufacturing to ensure smooth initiation of cGMP Projects.
· Participates in client communications, such as site visits and teleconferences as necessary.
· Provides written and verbal updates to Project Managers or other department heads as necessary.
· Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
· An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this position.
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