Job Desk
- Responsible for document control (SOP Management) and Data Governance and ensure that only effective documents are used in GMP areas.
- Responsible for document control and document destruction or GMP document including SOP, working instruction, specification, batch record distribution, obsolete document, and reminder for document periodical review.
- Responsible for master formula availability and update.
- Responsible for managing event/deviation handling including its investigation in coordination with all related departments.
- Responsible for personnel qualification monitoring and update.
- Responsible for product complaint, return and recall handling including mockup recall.
- Registration of event/deviation, assist investigation process of event/deviation, register CAPA.
- Responsible for Product Quality Report (PQR).
- Responsible for quality risk management implementation.
- Oversaw the Quality Assurance processes at Plant Manufacturing site aligning with GMP and Data Integrity Principles and other regulatory standards.
Requirement
- Bachelor Degree in Pharmacy/Apothecary, Engineering (e.g. Chemical).
- Experience in QA or related fields (DI Compliance/Compliance) for 1 – 2 years.
- Fluent in English (both spoken and written).
- Understand about Good Manufacturing Practice, Data Governance/Data Integrity, CAPA Management
- Understand about Aseptic Process & Sterile Facilities Concept.
- Has good Interpersonal Skill, Communication Skill and Decision Making Skill.
- Strong in detail orientation.
- Willing to work in various tasks,
- Having Good Initiative and Proactive.
- Good team player and strong personality.
