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
