Operational Quality Oversight

Date Posted: Posted30+ hari yang lalu
Salary:
Jakarta

Job Description

Site Name: Indonesia - DKI Jakarta - Jakarta Timur
Posted Date: Apr 4 2022


Are you energized by a Quality Assurance role that allows you to accelerate compliance in a highly technical and regulated environment? If so, this Operational Quality Oversight role could be an exciting opportunity to explore!

As an Operational Quality Oversight, you will be responsible for providing quality oversight at Production shop floor by conducting gemba, supervision, observation, coaching, and review of process, procedure, and documentation in order to support end to end supply of quality products based on regulatory standard and GSK Policy.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following.

  • Conduct real time investigation of incident, event, deviation, and other non-conformance to ensure that proper categorization and proper investigation is performed to addressed the issue
  • Provide real time quality impact assessment of any nonconformance/issue which has potential impact to product quality
  • Supervise in-process control (IPC) and other critical process in production area to ensure activity is conducted in compliance with applicable LSOP
  • Support qualification process of equipment and instrument by reviewing Qualification document and involved in the execution.
  • Perform batch documentation review to ensure that all products are manufactured in accordance with cGMP and QMS compliance from end to end manufacturing process
  • Perform CAPA Effectiveness check
  • Conduct Quality Management System Gap analysis for topic related to Quality Assurance
  • Ensure an effective process is in place for the training activities of all shift personnel
  • Mentoring and coaching of shop floor member in all relevant aspects of GMP
  • Monitor batch record review conducted in effective and compliance manner to ensure process compliance
  • Demonstrate and lead by example for the implementation of Good Documentation Practice

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

  • Bachelor degree, preferably Pharmacist

  • 1-3 years of experience in related field, fresh graduates are welcome to apply

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

  • Knowledge of cGMPs, local and international regulatory requirements
  • Strong analytical, numerical and reasoning skills
  • Able to work in teams effectively
  • Basic knowledge in manufacturing operations
  • Good technical writing and verbal communication skills in English
  • Good organization skills
  • Ability to effectively summarize findings and draw conclusions, considering interfaces/ links between quality processes
  • Good work ethics
  • Strong interpersonal and communication skills

Why GSK?

At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we’re making the most significant changes we’ve made to our business in over 20 years. We’re on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.

With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together – all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.

Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients – so we deliver what matters better and faster; accountable for impact – with clear ownership of goals and support to succeed; and where we do the right thing. So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together.

  • LI-GSK

Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.


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Job Detail

  • Job Id
    ff93b0e95f88b25f
  • Location
    Jakarta
  • Company
  • Type
    Private
  • Employment Status
    Permanent
  • Positions
    Available
  • Career Level
    Experience
  • Gender
    Male/Female

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