Responsibilities
- Management of site Standard Operating Procedures (SOPs) and documentation systems (including controlled copies management, document archival and retrieval) in accordance to company Quality Standards and ALCOA principles.
- Drive quality culture and promote GMP compliant behaviours at the site.
- Support improvement of quality systems in collaboration with cross functional teams.
- Handle duties related to DPOC (Designated Point of Contact) and super user for PDOCs system (e.g. configuration changes, user administration and periodic reviews).
- Lead or support investigations related to documentation systems, as required.
- Implement improvements to site SOP management and documentation systems, as necessary.
- Maintain inspection readiness and provide documentation support for internal and external GMP inspections.
- Actively participate in GMP walk downs to ensure documentation systems are maintained in inspection ready state and adhere to site procedures.
- Participate in gap analysis of site procedures against company Quality Standards and propose required actions to address identified gaps and mitigate risks.
- Maintain current quality tracking systems and quality metrics to proactively identify trends and atypical observations.
- Actively participate in Safety initiatives, and perform investigation related to EHS (as needed).
Requirements
- Bachelor Degree in Science/Chemical Engineering or Diploma in Phamaceutical/Chemical engineering or equivalent.
- Experience in pharmaceutical industry or related industry.
Tan Cheu Hoon, Fenny
EA License No.: 02C3423
Personnel Registration No.: R22105896
