QA Pharmacist-Operational Quality & Batch Release Section

Job Location

Ayutthaya Office (Hi-Tech Industrial Estate)

Job Summary

Monitors product quality to ensure strict compliance with Pharm aceutical Good Manufacturing Practices according to Thai Law (equivalent to PIC/s GMP) and other relevant GxPs as well as Marketing authorization.

Key Responsibilities

• Quality management in strict compliance with relevant GxPs.
• Product Quality and Marketing authorization compliance.
• Operational quality at the shop floor level to ensure strict compliance to the GMP, Quality Management System and local SOPs.
• Safety & Biosafety – manage the work place to prevent any accident in Operational Quality and Batch Release section.
• Customer service (Respect of company’s project/ production and testing schedule).

Activities

The followings are required, but not limited to, activities of this person:
• Coordinate with team members to ensure the assigned works are performed in a timely manner in order to meet project timelines.
• Defines operational quality system to promote and provide quality support at the shop floor level and assess it according to GMP and risk analysis.
• Ensures robustness and efficiency of the Quality management system implementation in relevant departments, i.e. personnel training, self-inspection, management review, external audit, supplier quality assurance, quality technical agreement, product recall and complaint etc.
• Implements and integrates quality risk management in the quality management.
• Ensure that impact of change control has been properly evaluated before implementing.
• Ensure that deviations in quality system are properly reported, investigated and corrective/preventive actions are implemented in a timely manner.
• Review and update standard operating procedures, specifications, protocols and records relevant to the Quality management systems as assignment from Head of Quality Assurance.
• Report to Head of Quality Assurance of any incompliance events and/or discrepancies which could impact quality, safety of products or process.
• Develops the batch release process to ensure accurate batch decision.

Other assignments:

• Other jobs assigned by superiors to support the organization achievement as well as corporation in company rule and regulations, safety policy and all activities according to company policy.
• Work in compliance with the company’s Health, safety & environm ent policy and procedures, regulations, requirement and manual.
• Report any incident, accident, near miss and any violations oft he 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 Equipment (PPE), safe operation of equip ment, machinery, tools and handling of hazardous substances.

Job Qualifications / Specifications

• Pharmacist.
• 0-2 years of experience in Pharmaceutical or Biological Industry in GMP environment is beneficial.
• Fluent in both written and spoken English.
• Good knowledge of GMP and other relevant GxPs