Responsibilities
- Author SOPs and associated GMP documentation related to site SOP management and documentation systems in accordance to PQS and ALCOA principles.
- Provide QA oversight of archival activities of hard copy GMP records into site archives and/or off-site facilities throughout required retention period to eventual records disposal, ensuring compliance with site SOPs.
- Manage control and issuance of GMP controlled documentation.
- Review and approve site documents (e.g. SOPs, forms) as document controller, ensuring adherence to site SOPs.
- Handle duties related to (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 PQS 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.
- Play an active and impactful role in Tier processes by updating performance against metrics, highlighting & resolving issues, with appropriate escalations.
- Collaborate with cross-functional teams to drive flawless execution.
- Actively participate in Safety initiatives, and perform investigation related to EHS (as needed).
Requirement :
- Bachelor Degree in Science/Chemical Engineering or equivalent.
- Min 2-3 years of QA experience
TELE me at @jacechooo or WA me at https://wa.me/+6582976283 NOW!
Interested candidates please submit your resume to [email protected]
Jace Choo Oi Kei
Personnel EA License No.: R1875164
Recruit Express Pte Ltd (EA Licence No.: 99C4599)
