Change & Documentation Supervisor - Depok, Indonesia - Bayer

Bayer

Perusahaan Terverifikasi

Depok, Indonesia

1 minggu yang lalu

Diposting oleh:

Siti Nur

beBee Recruiter

Change & Documentation Supervisor

JOB PURPOSE

Ensure that all the implementation of change is well managed
Periodically archive and review both manually system and online system for all of the GMP's documents. Coordinate with all departments to ensure all of GMP documents are in effective status and align with Bayer Healthcare Compliance Management System

YOUR TASKS AND RESPONSIBILITIES

Support the tasks of the QA System Manager in the process of change management
Control all of GMP documents so the documentation can be performed properly and correctly
Support internal and external audit process in term of change management and documentation area
Ensure and review the implementation of yearly GMP Training plan
Ensure no overdue SOP in each area/ department
Control electronic and nonelectronic documents so that only effective/ valid documents are located in the Cimanggis Site
Ensure GxP System Implementation as controlled document performed properly and correctly
Writing and/ reviewing SOPs in Change Management and Documentation area and updated in line with the newest version of related GSOP
Support of internal and external audit in PT Bayer, Cimanggis Site performed in timely manner
Ensure 100% CMS implementation in change management and documentation management area
Ensure that CAPA as result of audit in Documentation area are completely finished in timely manner
Quality Management Review (QMR) supported data from Change Management and Documentation Area in timely manner
Support maintaining appropriate precaution on occupational safety and health as well as security of facilities within Quality Department
Coordinating to evaluate HIRA (Hazard Identification Risk Assessment) of working area and ensure the completeness of HIRA training on the team and implementation of HIRA

WHO YOU ARE

Bachelor degree in Pharmacy / Apothecary / Chemical Engineering / Industrial Engineering
3+ years' experience in GMP aspects or related with the food supplement or drug manufacturing
Proficiency in oral and written in English
Understands and familiar with current GMP
Mastering computer operation for standard office
Have ability to create SOP and or other GxP documents
Has ability to work within team
Able to work with timeline
Able to work under pressure
Have good skill in leadership and communication
Have good integrity
Have good initiative
Have good personality

Application Period: