Job Description

Purpose:

• Ensure GMP compliance in daily operation.
• Ensure the product quality is under control.
• Establish and sustain a proactive and professional culture of quality assurance and regulatory compliance.

Responsibilities:

Daily QA Affaires

Shop Floor quality management

• Gemba, identify potential risk, help enhance the quality sense of the operator.
• Major shop floor issue handling

Quality issues handling

• Qualified investigator to lead or participate quality issue handling, investigation and assessment

Business support and continuous improvement

• Support PET business processes regarding compliance and quality
• Drive continuous improvement in process level
• Lead team project/support cross team project

Inspections and audit

• To be involved in regulatory inspections and self-inspection

Perform and deliver the quality activities assigned.
Additional requirement for Engineer responsible for incoming bulk and packing material evaluation

• Evaluate for Imported Bulks
• To maintain / improve efficient material evaluate procedure
• Release bulk/packing material
• To maintain / improve efficient material release procedure to ensure the product supply is maintained at a high quality standard.
• To take part in vendor audit
• Handle customer complaints, supplier complaints, material rejection, quality issues etc.

When take charge of the docs/samples archivist role:

• Ensure each team can follow document/sample archiving rooms’ procedures to conduct any archiving activities
• Ensure each team record all the activities and keep the proper track of docs/samples
   

Additional requirement for Engineer responsible for API/excipient evaluation

• To take part in vendor audit
• Release RM
• Handle customer complaints, supplier complaints, material rejection, quality issues etc.
• To maintain / improve efficient material release procedure to ensure the product supply is maintained at a high quality standard.
• Facilitate local vendor management and give support to GES/GDMS group

Additional requirement for responsible for warehousing and distribution management

• Ensure all the warehousing and distribution activities comply with the GXP requirement.

Quality system management

SHE responsibilities

Requirements:

- University graduate, major in pharmaceutical or related subjects

- Experience as quality assurance in PET is preferred    

- Good GMP and quality system management knowledge

- Knowledge of process control methodology and statistics, for example Cpk, FMEA

- Knowledge of product process and typical equipment

- Working knowledge of Microsoft applications, SAP or similar system

- Good English

- Good Computer skill

- Good communication skills, strong quality minds and strong service minds