Vacancies

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.