The posting
Documentation QA Specialist (Pharma GMP/ GxP/ Compliance)
12 Months Contract
Location: Tuas
Up to $8,000 depending on experience
Industry: Pharmaceutical
Our client aims at creating a new manufacturing concept consisting of a new generation of evolutive multi-product facilities, modular, adaptable, and agile, leveraging new disruptive technologies, to better address vaccine business challenges.
Job Purpose:
Documentation Management System:
- Maintaining the Document Management Processes to ensure that they meet company global quality standard requirements and fulfil the applicable regulatory expectations.
- Support the implementation of digital documentation solutions like electronic logbooks and manage the GMP governance and issuance of paper-bound logbooks on site.
- Support the implementation of digital documentation solutions like electronic forms and manage the GMP governance and issuance of controlled printing of forms on site.
- Perform archival of documents.
- Perform scanning of documents for electronic archival.
- Managing the GxP documentation lifecycle (creation, revision, and obsolescence)
- Collaborating with other departments to ensure document content addresses the business needs and processes
- Ensuring, with the support of relevant experts that the documentation content is compliant with regulatory requirements and company standards
- Ensuring the overall documentation package is kept lean (i.e., avoiding redundancies and duplication)
- Ensuring accuracy, completeness, and compliance of the documentation with writing rules (incl. clarity and grammar)
- Collecting needs for documentation changes, prioritizing and managing document update
- Ensuring the documentation is regularly updated to remain current and aligned with the needs and processes
- Ensuring document distribution and access complies with the information classification level
- Supporting internal and external audits and inspection by ensuring all required documents are up-to-date and retrievable
Requirements:
- Minimum 2 years experiences in Manufacturing, Validation, Quality in the pharmaceutical or biotechnology industry in vaccines and/or biologics.
- Good knowledge of regulations and standards of the pharmaceutical industry, Global Quality policies and data integrity requirements
Lim Pey Chyi - [email protected]
Recruitment Consultant (R2090579)
Manpower Staffing Services (S) Pte Ltd
EA Licence: 02C3423



