Manufacturing Specialist

2 weeks ago

Singapore PHARMENG TECHNOLOGY PTE. LTD. Full time

12-mth contract (1-mth bonus upon completion), Tuas, Singapore

**Job Purpose**

Supports effective GxP operations, qualification, and systems to ensure compliance of business areas with the Quality Manual and Policies and all relevant GxP, legal and regulatory requirements, KPIs (Key Performance Indicators) and KQIs (Key Quality Indicators).

**Major Accountabilities**
- Provision of administrative support services for system program set up and maintenance.
- Provision of set up and maintain of trackers for documentation life cycle and project timeline.
- Development and maintenance Manufacturing SharePoint to ensure all the documents are up to date.
- Provision of review, investigate and change control for non-routine event
- Support from delivering Batch Record to Manufacturing, as well as production walk down to ensure documentation compliance prior to audits.
- Support Project leaders in terms of Operational Excellence projects and improvement plans
- Support indicators set up and tracking using management tools to support GMP activities readiness.
- Provision of administrative support for documentations and training related activities to facilitate effective learning.

**Additional Specifications**

In addition to the defined accountabilities of Job Profile the following accountably are relevant:

- Provide timely and accurate support on Electronic and Paper batch records creation, review and release for production
- To make sure the Production Paper Record Package including SAP and other labels are printed and issued on time and in line with Production schedule
- Track and maintain controlled SOP and logbook locations in the production floor and en-sure its’ updated from time to time
- Will be trained on MES system

**Ideal Background**

**Education **(minimum/desirable):
BSc in Life Sciences, Biotech, or related experience (pharmaceutical manufacturing)

At least 2 year experience. Fresh graduate may be considered.

**Languages**:
English - fluent in speaking and writing.

**Experience**:
Good Office 365 competency

Operational Technology experience (i.e. DCS, programming and database) would be beneficial.

We regret that only shortlisted applicants will be notified.

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