Qualification Officer

Date Posted: Posted14 hari yang lalu
Salary:
Jakarta

Job Description

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.


Qualification Officer


MAIN PURPOSE


To support Qualification Supervisor and act as Qualification Lead with main focus on GMP Relevant of Technical System lifecycle and calibration review, including qualification activities according new installation, modification, and relocation issue.

YOUR TASKS AND RESPONSIBILITIES


  • Coordinate the Technical System lifecyle are implemented according to the updated SOP.
  • Preparing related document about Qualification activities (e.g. Qualification Plan, Qualification Protocol, and Qualification Report) according to the respective SOP.
  • Coordinate with other department (e.g. Engineering, Project, Quality, Operations, Supply Chain Management (SCM), Health Safety and Environment (HSE), and Technical Supply Management (TSM) that has Technical System issue, such as new installation / modification / relocation / retirement. And also coordinate with project lead related vendor schedule.
  • Execute qualification activities that has been scheduled with timely manner.
  • Monitor and control the calibration schedule in Cimanggis and ensure there are no overdue or uncalibrated status in critical parameter of technical system.
  • Conduct review calibration report and create tag calibration status.
  • Perform evaluation/investigation of deviations results related with the qualification issue.
  • Create and/or review of procedures (e.g. SOPs and templates) related to technical system lifecylce topic to ensure the procedures are aligned with the updated requirement (e.g.: CMS (Bayer Regulation: GOI, GSOP, Supplement, Best Practices, Local regulation such as CPOB, PICs).
  • Follow up the CAPA recommendation from validation activities in Dev@com System, and ensure the CAPA recommendation from validations are closed timely manner.
  • Follow up the CAPA recommendation from event/deviation/risk assessment in Dev@com system and enure the CAPA recommendation are closed timely manner.
  • Educate related person who relevant with qualification activities.
  • As a proxy of Qualification Supervisor if the Supervisor is not available.

WHO YOU ARE


  • Bachelor degree in Pharmacy / Apothecary / Chemical Engineering / Industrial Engineering or related area.
  • Having 1+ experience in GMP aspectes related with food supplement or drug manufacturing/fresh graduate is still applicable.
  • Having knowledge related with the manufacturing, packaging and cleaning validations requirements.
  • Having 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.
  • Good English skills.
  • Having high motivation to learn a new things
  • Having good writing and communication skill both in English and Bahasa




Application Period: 17 February 2022 Reference Code: 562871
Division: Consumer Health Location: Indonesia : DKI Jakarta Jakarta : Jakarta
Functional Area: Quality Position Grade: R09
Employment Type: 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

+622130491111

recruitment.indonesia@bayer.com

Related Jobs

  • Baru Data Engineer

    - PostedBaru dipasang

    Build a data lake, data warehouses and data marts as needed to support the company’s analytics needs. Design and develop necessary data pipelines, jobs, scripts…

  • Execute work in accordance with the service management framework by providing timely and accurate customer service. Ensure compliance on invoice processing.

  • EHS Supervisor

    - Posted30+ hari yang lalu

    You will support the team in preparing contracts for licensed hazardous and radioactive waste disposal firms, monitoring waste handling and organizing spill…

Job Detail

  • Job Id
    00e796fd3b7eaff1
  • Location
    Jakarta
  • Company
  • Type
    Private
  • Employment Status
    Permanent
  • Positions
    Available
  • Career Level
    Experience
  • Gender
    Male/Female

Contact Bayer

Sponsored by

https://halokerja.id connects jobseekers and recruiters by accurately matching candidate profiles to the relevant job openings through an advanced 2-way matching technology. While most job portals only focus on getting candidates the next job, Shine focuses on the entire career growth of candidates.

Latest Job