Regulatory Documentation Specialist

6 days ago


Singapore Pharmagend Global Medical Services Pte Ltd Full time
Job Description

We are seeking a highly skilled Regulatory Documentation Specialist to join our team at Pharmagend Global Medical Services Pte Ltd. In this role, you will be responsible for supporting the generation of cGMP documentation, including qualification protocols, SOPs, and production batch record issuance.

You will also coordinate internal review and approval of documentation, ensuring that all documents meet regulatory requirements. Additionally, you will proactively progress documents to achieve schedule adherence and compliance with cGMPs.

Your responsibilities will include initiating Production Change control, deviation, and handling related CAPA activities using Trackwise. You will assist in preparing reports/presentations as required and update and format documentation, including SOPs, forms, logbooks, and label templates.

Key Skills and Qualifications:
- Diploma qualification in life science, engineering, or related field
- Minimum 5 years' experience working in a regulated manufacturing environment
- Experience in a cGMP facility, in a documentation role is desirable
- Excellent computer skills in MS Office (WORD, EXCEL, Power Point)
- Good communication and interpersonal skills

Benefits of Working with Us:
- Opportunity to work with a leading pharmaceutical company
- Collaborative and dynamic work environment
- Professional development opportunities

Required Skills and Qualifications:
- Strong knowledge of cGMP regulations and guidelines
- Excellent organizational and time management skills
- Ability to work effectively in a team environment
- Strong communication and interpersonal skills

About Us:
Pharmagend Global Medical Services Pte Ltd is a leading pharmaceutical company dedicated to providing high-quality medical services. We are committed to excellence in all aspects of our business and strive to make a positive impact on society.

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