QA Specialist
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
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.
