Documentation QA Specialist (Pharma GMP/ GxP/ Compliance)

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 - [Confidential Information]

Recruitment Consultant (R2090579)

Manpower Staffing Services (S) Pte Ltd

EA Licence: 02C3423