Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
Major Responsibilities:
- Prepare controlled copy of BOP, Batch Record Production, Testing & Inspection report as per Shop Order that initiated by PPIC and ensure all prepared controlled copy are in correct version, format and comply to Good Documentation Practice prior it distributes to relevant area.
- Distribute all controlled copy document in timely manner as per respective procedure and assure the distribution activity are tracked in appropriate way as per Good Documentation Practice.
- Perform obsoletion of applicable QA/GMP Documentation and assure the retrieval process of obsolete controlled copy document is performed as per respective procedure.
- Prepare controlled copy of another QA document (including GMP document that provided by other Department in Abbott Cimanggis, where applicable)
- Perform filling and archiving of all documentation (e.g., master document, logbook, report, etc) that applied in QA Document Control as per respective procedure.
- Routinely update all applicable tracking/Document Control Logbook which related to preparation & distribution of controlled copy document; obsoletion & archiving activity of logbook, master document and other applicable document in QA Document Control.
- Periodically perform housekeeping activity in documentation storing area (e.g. QA file, etc)
- Perform other documentation activity such as.
- Stamping process for documentation effectivity
- Periodically update relevant QA list/Checklist which owned by QA Document Control
- Create/Revise BOP related to Document Control/Regulatory (if required)
- Handling relevant documentation that involving DARIUS system (e.g creation of DARIUS workflow, etc) (if required).
- Periodical checking on documentation compliance in relevant Area:
- Periodically (every 6 month) perform checking and ensure “controlled copy” BOP which prepared by each relevant Dept. is updated thru GEMBA system.
- Documented all checking activity thru GEMBA system in designated form for traceability purpose.
Requirements:
- Bachelor's Degree in Pharmacy
- Minimum 2 years of relevant experience in QA, preferably in document control
- Strong communication skills
- Able to work independently and in a team
- Strong attention to details
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