QA Documentation Lead
Lead all GXP related documents to ensure all documents are issued, maintained, stored, archived and retrieved properly throughout its life cycle.
Propose and control Function related budget, annual plans,
operational tactics, related Function development and corrective measures if
Support and mentor team members and colleagues to create a
collaborative and cohesive team environment.
Design procedure and assign responsible for issuing, modifying,
cancelling and periodic revision of all controlled GXP related documents.
Ensuring that all instructive documents (SOPs) are complying with
regulatory requirements and products marketing authorization files.
Monitor the process of drafting, revising and agreement on SOPs
from relevant stakeholders to ensure smooth and timely manner flow of
information and resolve conflicts if any.
Establish and improve tracking file to ensure that no invalid documents
are used or handled in the site.
Ensure that all suspended versions have been withdrawn, destroyed and
that originals are clearly marked obsolete and archived for life.
Ensure that current version of all documented information are made
available for relevant distributed departments in both paper and electronic
Monitor BPR generation in accordance with production plan in
timely manner and ensure that system prohibit generation of more than one
record for assigned / invalid batch or generation of record from suspended
10. Ensure adherence to the Company's Information
Management Policy, and Document Control Standard / Procedures.
11. Assure all necessary controlled document sets are up to
date, available and monitored.
12. Approve documentation plan for periodic revision issued
13. Review and amend master documentation periodically and
whenever needed to ensure reflecting current status.
14. Ensure that any departure from documentation procedure
have been reported, Investigated, assessed and corrected properly through
deviation / non-conformity system in a manner that prevent recurrence.
15. Propose to Quality Assurance Manager any forecast and
operational needs and provide periodical reports with appropriate analysis
regarding all documentation updates to ensure effective and accurate updated
16. Deliver the required on the job
training for all employees in the function to keep them qualified for doing
their jobs properly.
17. Fulfill other related tasks as asked by management and
as arising from the business.
Degree in Science.
10+ Years of Experience in Mid-Managerial level preferred Pharmaceutical Industry
Years of Experience:
4 January 2022
Application End Date:
18 January 2022
QA - Documentation