Baru QA System Manager

Date Posted: 1 hari yang lalu
Salary:
Bayer
Jakarta
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Job Description

QA System Manager





YOUR TASK & RESPONSIBILITIES


  • Co-ordinate of CMS (Compliance Management System) implementation from the Bayer regulation and authority regulation are applied in Cimanggis site.
  • Co-ordinate of Technical System Lifecycle (qualification, maintenance and calibration) are implemented according to the updated GMP relevant requirement.
  • Co-ordinate of Supplier and service providers management activity according life cycle of the process.
  • Coordination documentation and training management are managed according to the GMP requirement.
  • Maintain audit management program within Cimanggis including supplier audit and the CAPA follow up.
  • Manage change management activity to ensure the implementation of the change is in compliance with quality and regulatory requirement.
  • Monitor Site Quality Management Reviews with subsequent follow up on CAPAs defined.
  • Supervising the plant(s) for all GMP/GDP-related inspections and being primary contact with BPOM for site certification.
  • Maintain Site Master File document in updated situation.
  • Ensuring that in case of discrepancies investigations are made to determine the root cause and corrective actions are defined.
  • Being second deputy of Head of Quality, dealing with any decision related to quality aspects which is urgent to be taken during absence.
  • Support global investment projects for Bayer Cimanggis in the implementation phase.
  • 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


  • Pharmacist with 5+ years’ experience in GMP aspects or related areas
  • Deep knowledge on international and local GMP principles for manufacturing of pharmaceutical products and Food supplements and Halal Management System.
  • Skilled to work within an international team and ability to work within teams.
  • Having good Leadership experience & have experience for managing teams more than 10 peoples.
  • Professional English skills. Able to resist any influence, which would hamper management decision making during the absence of Head of Quality
  • Having deep knowledge related with the qualification activities requirements.
  • Understands know how on current GMP as well as other relevant national and international regulations for pharmaceutical products (GMP codes).
  • Be familiar with BHC GMP Policies and Directives through training to enable controlling implementation into local practices.
  • Can operate the computer program (Microsoft office) Having high motivation to learn a new things Having good writing and communication skill both in English and Bahasa Having good skills on teach the member.




Application Period: 13/09/2021 Reference Code: 475282
Division: Consumer Health Location: Indonesia : DKI Jakarta Jakarta : Cibubur Jakarta
Functional Area: Quality Position Grade: VS 1.1
Employment Type: Regular Work Time: Flexi Hours (8 working hours)



Contact Us

Address Telephone E-Mail
PT Bayer Indonesia
Menara Astra, 33rd floor
Jl. Jend. Sudirman Kav.5-6, Jakarta 10220, Indonesia

+62213049111

recruitment.indonesia@bayer.com

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Job Detail

  • Job Id
    014ffa744fde0054
  • Location
    Jakarta
  • Company
    Bayer
  • Type
    Private
  • Employment Status
    Permanent
  • Positions
    Available
  • Career Level
    Experience
  • Gender
    Male/Female

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