Quality Assurance Staff 3 (Operational quality &Batch Release Section)BioNet-Asia Co., Ltd.

Degree

Five-day work week
Free shuttle bus
Life insurance
Medical insurance
Performance bonus

Job Location:  Ayutthaya Office (Hi-Tech Industrial Estate)
Job Summary:
            Quality Assurance Staff 3monitor product duality to ensure strict compliance with Pharmaceutical Good Manufacturing Practices and other relevant GxPs as well as marketing authorization.
 
Key Responsibilities:
Quality management to strict compliance with relevant GxPs.
Production Quality and Marketing authorization compliance.
Operational quality at the shop floor level to ensure strict compliance to GMP, Quality Management System, Bio risk management system, Quality Directives and local SOPs.
Follow up for observation response action from the area to remove the observation.
Activity:
The following are required, but not limited to, activities of this person:
Quality management system:
Ensure robustness and efficiency of the quality management system implementation at the shop floor level.
Ensure the activities compliance the GMP, Quality Management system, Bio risk management and operations.
Implement and integrate quality risk management in the quality management and operations.
Operational quality:
Provide operational quality support at the shop floor level and assess it according to GLP/GMP and risk analysis.
Initiate shop floor operational observation report to report the observation and follow up for observation response action from the area.
Follow up with production and quality QC to gather recorded BPR and QC test report.
Archive and keep logbook of batch record receiving and reviewing up-to-date.
Support the batch release process to ensure accurate batch decision.
Issue status tag of finished product and attach on the finish product and keep the record up-to-date.
Issue batch certificate for batch release product.
Notify QA Supervisor (Quality system & Operational quality) of any deviation or issues related to the batch release plan and/or results.
Conduct spot check in production/QC Laboratories to verify strict application of SOPs. GMP and Quality directives.
Report to QA Supervisor (Quality system & Operational quality) of any non-compliance events and/or discrepancies which could impact quality and safety of production or GMP.
Other job assigned by supervisor to support the organization as well as corporation in company rule and regulation, safety policy and all activities according to company policy.
Work in compliance with the company's Health, safety & environment policy and procedures, regulations, requirement and manual.
Report any incident, accident, near miss and any violations of the HSE or safe work practices including malfunctioning of the equipment or workplace hazards that he/she is aware of to the direct supervisor.
Follow the health and safety including biosafety procedures related to the job functions, which includes the use of personal protective (PPE), safe operation of equipment, machinery, tools and handing of hazardous substances.
Ideal candidate:
Bachelor of Science B.Sc.,(Microbiology, Biotechnology, Pharmaceutical or related field)
Experience at least 1-2 years in pharmaceutical or biological industry in GMP environment.
Fluent in both written and spoken English
Good knowledge of GMP and other relevant GxPs.
To Apply : Please submit your resume in MS Word with recent photo stating present and
expected salary by click "Apply Now"
Human Resources Department
BioNet-Asia Co., Ltd.
Plant:Hi-Tech Industrial Estate, 81 Moo 1, Baan-Lane, Bang Pa-In,
Ayuttaya 13160 Thailand
Website: www.bionet-asia.com
*All applications will be accepted by mail attached in MS. Word only.