Product Quality Executive

Job Responsibilities

· Lead in the implementation of Quality Management System in accordance with internal company policies and procedures, cGMP and other international regulations.

· Update complaints retrieved from various sources to complaint log in a timely manner and escalate complaints into the CAPA system following review.

· Participate in Product Quality activities by reviewing test protocols, reports, batch records and analytical data to ensure product quality meet the specified requirements.

· Review OOS investigation, deviation, CAPA and risk management for products as required.

· Review product quality documents and provide documents related to product quality upon request.

· Draft and review Quality Technical Agreements

· Provide management with quality data and trends as required.

· Lead internal audits to ensure the effective implementation of Quality Management System as required.

· Lead audits in DS and DP CMOs to ensure compliance to all relevant guidelines, regulations and agreements.

· Provide training and guidance to personnel on quality assurance procedures, regulations, and best practices.

· Mentor junior QA staff and contribute to their professional development.

· Any other duties as assigned by supervisor.

Education/Qualification

· Degree in Engineering (Biomedical) or Degree in Science (Biology, Chemistry,

Bio-engineering)

· Experience in quality function dealing with Biopharmaceuticals with 3 to 5 years experience.

· Experience in Bioprocessing Technology (Upstream and Downstream operations).

· Minimum of 3-5 years of experience in pharmaceutical quality assurance, with a focus on product quality management and compliance.

Skills preferred

· Strong analytical and problem-solving skill

· Good computer skills, inclined to adapt to technology efficiently.

· Results-oriented, multi-tasking, quick learner

· Works independently and well under tight deadlines

· Good knowledge and thorough understanding of cGMP, FDA regulations, ICH guidelines, and other relevant regulatory guidelines and quality standards.

· Strong analytical skills and attention to detail, with the ability to critically evaluate data and identify trends.

· Excellent oral and written communication skills, with the ability to effectively collaborate with cross-functional teams and communicate complex issues to diverse audiences.

· Proven track record of conducting audits, investigations, and implementing corrective actions.

· Team-player