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