Department:Quality Unit



Documentation Lead - QA


Lead all GXP related documents to ensure all documents are issued, maintained, stored, archived and retrieved properly throughout its life cycle.

Job requirements:

1.      Propose and control Function related budget, annual plans, operational tactics, related Function development and corrective measures if necessary.

2.      Support and mentor team members and colleagues to create a collaborative and cohesive team environment.

3.      Design procedure and assign responsible for issuing, modifying, cancelling and periodic revision of all controlled GXP related documents.

4.      Ensuring that all instructive documents (SOPs) are complying with regulatory requirements and products marketing authorization files.

5.      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.

6.      Establish and improve tracking file to ensure that no invalid documents are used or handled in the site.

7.      Ensure that all suspended versions have been withdrawn, destroyed and that originals are clearly marked obsolete and archived for life.

8.      Ensure that current version of all documented information are made available for relevant distributed departments in both paper and electronic format.

9.      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 version.

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 from system.

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 records.

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.


B.Sc. Degree in Science.

10+ Years of Experience in Mid-Managerial level preferred Pharmaceutical Industry or FMCG.

Years of Experience: 10

Posting Date: 3 February 2022

Application End Date: 17 February 2022

Available Vacancies: 1

Job Level: Lead

Function: QA - Documentation