Quality Assurance Associate Manager_QA 副理

About Bora

Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing, and packaging of complex oral solid dose, liquid, semi-solid, biologics, and sterile injectable pharmaceutical products.

From our world-class sites in North America and Asia, we deliver drug products with unparalleled quality to more than 100 markets around the world. Bora’s teams, technologies, and facilities work seamlessly together to enable our clients to deliver much-needed therapeutics to patients worldwide.

At Bora Pharmaceuticals, we see it as our mission, our duty, our responsibility, to make our success and our customer’s success more certain.

Job Summary:   Develops, implements, and coordinates product assurance program to prevent or eliminate defects in new or existing products by performing the following duties personally or through subordinates.

 

Responsibilities:

 

• Review technical problems, and subsequently suggest and debate alternative methods and procedures to solving problems or changes in procedures.
• Modify product assurance programs to clarify areas or roles of responsibility, staffing requirements, and operational procedures.

• Supervise and final approve investigations relating to root cause of customer complaints, manufacturing, and laboratory deviations, and review, approve and implantation oversee  corrective and preventative actions, and effectiveness check as required.

• Support Supplier Quality Management program for supplier qualification and supplier risk management.

• Ensure quality assurance of newly designed and manufactured products by supporting manufacturing and QA’s investigations and to confer with engineers to rectify problems.
• Ensure the practicable goal for quality metrics are established and the performance are monitored for continually improvement.
• Develop and maintain a suitable documentation control system to ensure compliance with applicable regulations and procedures.
• Develop and maintain a suitable training system to ensure compliance with applicable regulations and procedures.
• Develop, review and approve GMP documents (e. g., standard operating procedures, forms, validations, batch records and specifications, etc.) to ensure compliance with applicable regulations and customer’s quality requirement.
• Ensures release of raw/packaging materials and finished products met criteria and compliance.
• Oversee the management of the analytical database for inter-department use, and ensure valid evaluation of stability trend and analytical data.
• Manage EM, CV, Cross Contamination program, data collecting and generating reports.
• Oversee the equipment qualification and computer system validation procedure to meet company and regulatory requirements.
• Monitors the QA systems for improvement, review/approval function for GMP documents.
• Provide hands-on training and reinforces cGMPs concept to increase quality and compliance knowledge throughout manufacturing site.
• Ensure all activities and operations met cGMP compliance. Monitor regulatory updates and industry news to ensure site compliance.
• Review and oversee quality risk management of the site for risks evaluation, control and mitigation as required.
• Other tasks as assigned by the company.

 

Qualifications:

• Majored in chemistry, biomedical, or engineering related background and with 4 years of pharmaceutical industrial experience or above (preferable for aseptic operation). Or equivalent combination of education and experience.
• Requires the ability to provide guidance to junior staff under supervision and is a steppingstone to more senior QA leadership positions. It requires strong technical knowledge, communication skills, and attention to detail.
• cGMP Compliance:

Demonstrated experience in current Good Manufacturing Practices and regulatory standards.

We offer a comprehensive benefits package designed to support our employees’ wellbeing, including:

- Competitive salary and performance-based incentives

- Comprehensive health coverage including medical, dental, and vision insurance

- Retirement savings plans with employer contributions

- Paid time off and flexible work arrangements

- Professional development opportunities

- Employee wellness programs and resources

- Employee Assistance Program and Mental Health Resources

At Bora, our values guide everything we do — from how we solve challenges to how we support our people. We lead with a solutions-first mindset, strive to do the right thing, stay proactive, and above all, respect everyone. Bora Pharmaceuticals  is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Bora Pharmaceuticals will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.