Manufacturing Excellence/ Technical Writer/ Deviation Writing/ Manufacturing Expert/ Deviation [...]

Recruit Express Pte Ltd.; Singapore; On-site; SGD 40,000 - 80,000; Full time

Job summary

An established industry player is seeking a Technical Writer with expertise in cGMP processes. This role involves drafting crucial documentation, ensuring compliance with GMP regulations, and collaborating with various teams to facilitate project initiation. You will play a key role in maintaining high standards in manufacturing excellence while managing multiple projects in a fast-paced environment. If you are detail-oriented and possess strong communication skills, this opportunity could be your next career move in the healthcare and lifesciences sector.

Qualifications

• 3+ years of relevant experience in a cGMP environment.
• Strong communication skills with cross-functional teams.

Responsibilities

• Drafting Master Production Records and ensuring compliance with cGMP.
• Coordinating document reviews and tracking documentation flow.

Skills

GMP / cGMP regulations

Communication Skills

Time Management

Attention to Detail

Project Management

Education

Bachelor Degree or equivalent work experience

Tools

Microsoft Word

Microsoft PowerPoint

Microsoft Excel

Job description

Manufacturing Excellence/ Technical Writer/ Deviation Writing/ Manufacturing Expert/ Deviation Writer

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 [e-mail]

Thank You.

R1551708

Recruit Express Pte Ltd (Healthcare & Lifesciences Division)