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!
This role is open for 12 months contract and be based in our manufacture site in Jakarta Timur.
As an Operational Quality Oversight , you will manage overall operational quality oversight (to oversee, supervise, observe and review all activities) at the shop floor during shift hours and to ensure that all activities comply with GSK and regulatory agencies standards by working in a collaborative manner with the shift operators and their team leaders.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following.
Real time review of incidents, issues and events in manufacturing to determine the correct incident categorization, investigation and quality approval. Review of GMP failures and any other failures in the process or quality systems on site to ensure the appropriate investigation is triggered as soon as practical. Ensure a process is in place for investigating quality related issues with appropriate Quality oversight. Ensure that where necessary the root cause analysis process is followed for critical incidents and deviations, recurring deviations and major deviations as necessary with appropriate quality oversight. Provide real time quality impact assessment of Equipment breakdowns and issues. Real time assessment of unplanned changes. Approval of Lab OOS for further testing to support QC Shift. Support customer complaint investigation (for topical product) assigned by OQ Manager. Supervising In process Quality Checks (IPQC) activity in production to ensure this activity incompliance with applicable SOP. Conduct In use review of procedures for shift staff to ensure that standard operating procedures are clear and can be followed in a consistent and standard manner. Ensure an effective process is in place for internal audits and 5S programs in shift operated areas of site. Support investigation deviation assigned Support process qualification assigned Review production documentation and records. Monitor on line batch record review conducted in effective and compliance manner to ensure process compliance. Good documentation practice – demonstrate or lead by example in relation to correct ways of handling documentation and recording of GxP data. Support OQ Manager to review document QC Conduct GMS GAP Analysis in area QC Coordinator Review Log Book QA
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Holds bachelor degree in Pharmacy. Fresh graduates are welcome to apply
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
Fluent in English - both verbal and written Previous leadership experience Strong interpersonal and communications skills Proven experience assuring compliance with regulations
