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 - Apple.lim@manpower.com.sg Recruitment Consultant (R2090579) Manpower Staffing Services (S) Pte Ltd EA Licence: 02C3423