Taiwan reputable biotech company - QC Senior Leader

工作内容

Taiwan Reputable Biotech Company - QC Senior Leader

• Embrace a leadership role at our client’s forward-thinking biotechnology firm|Commitment in developing new drugs
  

About Our Client

Our client is a well-established and respected biotechnology company based in Taiwan, renowned for its dedication to advancing pharmaceutical solutions. With a strong commitment to quality, innovation, and compliance, our client has garnered a reputation for delivering high-quality pharmaceutical products. Operating at the forefront of the industry, they offer a dynamic and collaborative work environment that encourages professional growth and the opportunity to contribute to the development of impactful healthcare solutions.

Job Description

As a QC Manager / Senior Manager, you will play a pivotal role in ensuring the quality and compliance of our client’s pharmaceutical products. Your responsibilities will include:

• Leadership and Oversight: Lead and manage the QC team, providing guidance, training, and mentorship to ensure accurate and efficient execution of quality control processes.
• Quality Control Operations: Oversee and manage the daily operations of the QC department, including testing and analysis of raw materials, intermediates, and finished products, ensuring adherence to established procedures and GMP regulations.
• GMP Compliance: Ensure strict compliance with Good Manufacturing Practices (GMP) regulations and guidelines. Establish and maintain a deep understanding of GMP requirements to ensure accurate implementation within the QC department.
• Process Improvement: Continuously assess and optimize QC workflows and procedures to enhance efficiency, accuracy, and productivity. Identify areas for improvement and implement appropriate solutions.
• Client and Authority Interaction: Possess strong English communication skills to confidently interact with clients and regulatory authorities during facility inspections and audits. Address inquiries, present findings, and provide necessary documentation as required.
• Documentation and Reporting: Oversee the preparation and review of QC-related documentation, including test methods, protocols, reports, and standard operating procedures (SOPs). Ensure accurate and thorough record-keeping.
• Team Collaboration: Collaborate closely with cross-functional teams, including R&D, Production, and Regulatory Affairs, to ensure seamless communication and alignment on quality-related matters.
  

The Successful Applicant

• Mandarin speaking is required
• Bachelor’s degree or higher in a relevant scientific discipline.
• 8-10 years of experience in a pharmaceutical manufacturing environment, with a strong focus on Quality Control operations, preferably within biotech or pharmaceutical companies.
• In-depth knowledge of GMP regulations and quality control processes is essential.
• Proficiency in written and spoken English, enabling effective communication with clients and regulatory authorities.
• Experience in client-facing roles or interactions with regulatory authorities is a plus.
• Strong analytical and problem-solving skills, with the ability to lead process improvements.
• Location: The position is based in Hsinchu County. Candidates from the Hsinchu or nearby areas are preferred.
  
  

Nice-to-Have:

• Experience in analytical method development is a plus, demonstrating a well-rounded understanding of pharmaceutical QC.
• Familiarity with small molecule quality control processes.

What’s on Offer

The company fosters a culture of continuous learning, offering ample opportunities for personal and professional development as you shape the future of pharmaceutical quality control.

Contact: Jenny I Wang

Quote job ref: JN-062023-6082619