Quality Assurance Supervisor

Who is Bora

Bora Pharmaceuticals is a premier global contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing, and packaging of complex oral solid-dose, liquid, and semi-solid pharmaceutical products. We believe in the power of passion, innovation, and collaboration, and we're on the lookout for individuals who share our vision.

If you want to know more, please visit our official website, https://bora-corp.com/

Why Bora

We believe that people are our greatest asset - people are the key to driving everything. Making success more certain is our belief. Our vision is to let the world know Bora and make contributions to all mankind. We hope to help people live longer, happier, and healthier lives.

If you want to be part of a growing company where contributions are highly valued and rewarded, Bora is a place for you!

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Job Summary:

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

Responsibilities:

• Support all activities and operations met cGMP compliance.
• Review technical problems, and subsequently suggest and debate alternative methods and procedures to solve problems or changes in procedures.
• Review information related to supply quality and vendor quality standards.
• Support release of raw/packaging materials and finished products met criteria and compliance.
• Review the management of the analytical database for inter-department use, and ensure valid evaluation of stability trend and analytical data to provide and establish accurate analytical database.
• Review the equipment qualification procedure of QC laboratory to meet company requirements.
• Monitors the QA system for improvement, review/approval function for GMP documents.
• Ensures training of Release QA team on GMP concept is undertaken on at least an annual basis to emphasize and enhance the GMP requirements.
• Support the review of quality issues/trends is done systematically, eliminate any potential risk when significant trend is found.
• Maintain a suitable QA system to complying with customers, regulations and procedures.
• Liaises with external groups on quality assurance related issues where applicable to improve quality function.

Qualifications:

• B.S. degree with at least 6 years pharmaceutical industrial experience. Or a MS degree with 4 years pharmaceutical industrial experience. Or equivalent combination of educations and experience.
• Leadership –Takes responsibility for subordinates’ activities; provides regular performance feedback; develops subordinates’ skills and encourages growth. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
• Delegation – Delegates work assignments; gives authority to work independently while ensuring positive outcome.
• Quality Management – Looks for ways to improve and promote quality; demonstrates accuracy and thoroughness.
• Problem Solving – Identifies and resolves problems promptly; develops alternative solutions; problem solves well in group situations.
• Shall have cGMP compliance experience.