Tuyển dụng Process Quality Assurance Staff tại Đồng Nai

• Job Summary

The position will be responsible for process quality assurance in Terumo BCT, Vietnam facility (TBV). The candidate will execute manufacturing improvements and incorporate methods within the process to prevent non-conformities. The position requires the ability to perform verifications on new or improved processes. The candidate will also support the management team to achieve company goals and directives.

• Essential Duties

Skill Set #1

• Action for process deviation and management of the deviation control.
• Ability to follow standard operating procedures for process deviation and control.
• Ability to perform root cause analysis and identify affected product.
• Provide recommended actions and solutions for non-conforming product.
• Execute recommended actions for non-conforming product.
• Write a deviation report for non-conforming product.
• Participate in quality improvements to prevent re-occurring non-conformities.
• Support the customer complaint answer report and recording.

Skill Set #2

• Identify the problem and potential problem and improvement suggestions by process control.
• Verification of process improvement items proposed by technical section or production section.
• Analysis of process defects

Skill Set #3

• Support Quality System Monitoring and Audit Coordination
• Perform Layered Process Audit (LPA) program.
• Coordinate with relevant functions to support LPA planning, execution, follow-up, and closure of identified issues.
• Monitor completion of LPA checksheets and maintain LPA records.
• Prepare periodic summaries and trend reports of LPA results for management review.
• Coordinate facility and logistics preparation for internal, customer, regulatory, and certification audits.
• Support procurement and administrative activities related to audit programs, external consultants, and quality standards when required.
• Follow up on audit findings, verify completion evidence related to audit findings.
• Support preparation of periodic quality and audit performance reports.

Yêu cầu công việc

• Minimum Qualification Requirements
• Education - University or college graduate (minimum requirement)
• Preferably Engineering or Pharmaceutical Degree
• Experience
• Requires a wide-range of knowledge including production, quality, personnel management, and regulation and strong leadership for compiling organization.
• A minimum of 1 year experience is required in a similar field.

Skills

• Ability of preparing plans through understanding product's knowledge, market, and strategy.
• Ability of judging and advising actions for improvement objectively based on knowledge of manufacturing facilities, required quality, and production technology.
• Knowledge of products and customer usage of product
• Having done for education/training of GMP, validation, safety, document control, pharmaceutical law, 5S, and manufacturing control.
• Understanding outline and operational knowledge of calibration and validation.
• Ability for data processing and analyzing.
• Good verbal and written communication ability in English.
• Knowledge and use of relevant PC software applications and skills to use them effectively.
• Giving direction for personnel management and education/training of operator and having management skill.
• Physical Requirements

General Labor Environment requirements include use of personal protective equipment, reading, speaking, hearing, walking, bending, standing, stretching/reaching, hand/finger dexterity, and occasional lifting up to 25 kgs.

The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

• Additional Requirements

Needs to work in all shifts.

Quyền lợi được hưởng

• No Probation Required
• Private Healthcare Program
• Paid Leave: Annual & public holidays per Labor Law.
• Allowances & Equipment: Transport, attendance, team allowance, company laptop & mobile allowance.
• Shuttle Bus: Daily transport from HCMC & Bien Hoa.
• Company Canteen: Nutritious & affordable meals.